logo

Selected New Drugs [ 2017  ]

Disclaimer - Please see package insert if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   [  Read the disclaimer    |   <<Back    ]

BAXDELA™ (delafloxacin)  top of page

Drug UPDATESBAXDELA™ (delafloxacin) tablets |  Fluoroquinolones

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
BOXED WARNING
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including:

Tendinitis and tendon rupture (5.2)
Peripheral neuropathy (5.3)
Central nervous system effects (5.4)
Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions (5.1)

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. (5.5)

Initial U.S. Approval:  2017

Mechanism of Action:
Delafloxacin belongs to the fluoroquinolone class of antibacterial drugs and is anionic in nature. The antibacterial activity of delafloxacin is due to the inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes which are required for bacterial DNA replication, transcription, repair, and recombination. Delafloxacin exhibits a concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.

INDICATIONS AND USAGE:
BAXDELA is a fluoroquinolone antibacterial indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. (1.1)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2)

DOSAGE AND ADMINISTRATION:
See package insert: [Drug information  /  PDF
Administer BAXDELA for injection 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450-mg BAXDELA tablet orally every 12 hours for 5 to 14 days total duration. (2.1)
Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR) (2.3)

Renal dosing:
Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m2)
Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation.

>30 mL/min: no change

15 - 29 mL/min:
    Tablets: no change.
    IV: 200 mg q12h

ESRD: NOT recommended



HOW SUPPLIED:
BAXDELA for Injection
BAXDELA is supplied as a sterile, lyophilized powder in single-dose clear glass vials of 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine). The lyophilized powder is a light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and color.

They are supplied as follows: 300-mg single-dose vials (NDC 70842-102-03), packaged in cartons of 10.

BAXDELA Tablets
BAXDELA Tablets contain 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine); each modified capsule-shaped tablet in beige to mottled beige color is debossed with RX3341 on one side. They are supplied as follows:

Bottles of 20 tablets with child-resistant closure (NDC 70842-101-01)

Unit dose blister packs which contain 20 tablets (2 blister cards of 10 tablets each) (NDC 70842-101-02)

Storage and Handling
BAXDELA Tablets and BAXDELA for Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

The reconstituted powder may be stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion. The reconstituted solution in the infusion bag may be stored under refrigerated or controlled room temperature conditions for up to 24 hours [see DOSAGE AND ADMINISTRATION (2.4)]. Do not freeze.


BEVYXXA ® (betrixaban) capsules  top of page

Drug UPDATESBEVYXXA ® (betrixaban) capsules
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
BOXED WARNING
WARNING: SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. The risk of these events may be increased by the use of in-dwelling epidural catheters or the concomitant use of medical products affecting hemostasis. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures [see WARNINGS AND PRECAUTIONS (5.2)].

Initial U.S. Approval:  2017

Mechanism of Action:
Betrixaban is an oral FXa inhibitor that selectively blocks the active site of FXa and does not require a cofactor (such as Anti-thrombin III) for activity. Betrixaban inhibits free FXa and prothrombinase activity. By directly inhibiting FXa, betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.

INDICATIONS AND USAGE:
BEVYXXA is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE [see CLINICAL STUDIES (14)].

Limitations of Use:
The safety and effectiveness of BEVYXXA have not been established in patients with prosthetic heart valves because this population has not been studied.

DOSAGE AND ADMINISTRATION:
2.1 Recommended Dose
The recommended dose of BEVYXXA is an initial single dose of 160 mg, followed by 80 mg once daily. Daily oral doses should be given at the same time of day with food.

The recommended duration of treatment is 35 to 42 days.

2.2 Severe Renal Impairment
For patients with severe renal impairment (CrCl >/= 15 to < 30 mL/min computed by Cockcroft-Gault using actual body weight) the recommended dose of BEVYXXA is an initial single dose of 80 mg followed by 40 mg once daily [see WARNINGS AND PRECAUTIONS (5.3), USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)]. The recommended duration of treatment is 35 to 42 days.

2.3 Use with P-gp Inhibitors
For patients receiving or starting concomitant P-gp inhibitors the recommended dose of BEVYXXA is an initial single dose of 80 mg followed by 40 mg once daily [see WARNINGS AND PRECAUTIONS (5.4), DRUG INTERACTIONS (7.1), CLINICAL PHARMACOLOGY (12.3)]. The recommended duration of treatment is 35 to 42 days.

2.4 Missed Dose
If a dose of BEVYXXA is not taken at the scheduled time, the dose should be taken as soon as possible on the same day. The BEVYXXA dose should not be doubled to make up for a missed dose.

HOW SUPPLIED:
BEVYXXA (betrixaban) capsules are available as listed below.

The 40 mg size 4 capsules are light grey with 40 printed in black, and have a light blue cap with PTLA printed in white.

Bottles of 100 (NDC 69853-0202-1)
The 80 mg size 2 capsules are light grey with 80 printed in black, and have a blue cap with PTLA printed in white.

Bottles of 100 (NDC 69853-0201-1)

Storage and Handling:
Store at room temperature; 20°C to 25°C (68°F to 77°F).


EMFLAZA ™ (deflazacort) tablets  top of page

Drug UPDATESEMFLAZA ™ (deflazacort) tablets
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
Deflazacort is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.

INDICATIONS AND USAGE:
EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

DOSAGE AND ADMINISTRATION:
2.1 Dosing Information
The recommended oral dosage of EMFLAZA is approximately 0.9 mg/kg/day once daily. If tablets are used, round up to the nearest possible dose. Any combination of the four EMFLAZA tablet strengths can be used to achieve this dose. If the oral suspension is used, round up to the nearest tenth of a milliliter (mL).

2.2 Discontinuation
Dosage of EMFLAZA must be decreased gradually if the drug has been administered for more than a few days [see Warnings and Precautions (5.1)].

2.3 Important Preparation and Administration Instructions
EMFLAZA Tablets and Oral Suspension can be taken with or without food.

EMFLAZA Tablets
EMFLAZA Tablets can be administered whole or crushed and taken immediately after mixing with applesauce.

EMFLAZA Oral Suspension
Shake EMFLAZA Oral Suspension well before administration.

Use only the oral dispenser provided with the product. After withdrawing the appropriate dose into the oral dispenser, slowly add the EMFLAZA Oral Suspension into 3 to 4 ounces of juice or milk and mix well. The dose should then be administered immediately. Do not administer EMFLAZA with grapefruit juice [see Drug Interactions (7.1)].

Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.

2.4 Dosage Modification for Use with CYP3A4 Inhibitors and Inducers
CYP3A4 Inhibitors
Give one third of the recommended dosage when EMFLAZA is administered with moderate or strong CYP3A4 inhibitors. For example, a 36 mg per day dose would be reduced to a 12 mg per day dose when used with moderate or strong CYP3A4 inhibitors [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

CYP3A4 Inducers
Avoid use with moderate or strong CYP3A4 inducers with EMFLAZA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].



HOW SUPPLIED:
EMFLAZA Tablets

6 mg are white, round with “6” debossed on one side. They are supplied as follows:
NDC 42998-501-01 Bottle of 100 tablets
18 mg are white, round with “18” debossed on one side. They are supplied as follows:
NDC 42998-502-03 Bottle of 30 tablets
30 mg are white, oval with “30” debossed on one side. They are supplied as follows:
NDC 42998-503-03 Bottle of 30 tablets
36 mg are white, oval with “36” debossed on one side. They are supplied as follows:
NDC 42998-504-03 Bottle of 30 tablets
EMFLAZA Oral Suspension

22.75 mg/mL is a whitish colored suspension. Supplied as 13 mL in a 20 mL bottle packaged with two 1 mL oral dispensers.
NDC 42998-505-21

16.2 Storage and Handling
Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.

Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.

IDHIFA® (enasidenib) tablets  top of page

Drug UPDATESIDHIFA® (enasidenib) tablets

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)


BOXED WARNING
WARNING: DIFFERENTIATION SYNDROME
Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Initial U.S. Approval:  2017

Mechanism of Action:
Enasidenib is a small molecule inhibitor of the isocitrate dehydrogenase 2 (IDH2) enzyme. Enasidenib targets the mutant IDH2 variants R140Q, R172S, and R172K at approximately 40-fold lower concentrations than the wild-type enzyme in vitro. Inhibition of the mutant IDH2 enzyme by enasidenib led to decreased 2-hydroxyglutarate (2-HG) levels and induced myeloid differentiation in vitro and in vivo in mouse xenograft models of IDH2 mutated AML. In blood samples from patients with AML with mutated IDH2, enasidenib decreased 2-HG levels, reduced blast counts and increased percentages of mature myeloid cells.

INDICATIONS AND USAGE:
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test

DOSAGE AND ADMINISTRATION:
2.1 Patient Selection
Select patients for the treatment of AML with IDHIFA based on the presence of IDH2 mutations in the blood or bone marrow [see Indications and Usage (1.1) and Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of IDH2 mutations in AML is available at HTTP://WWW.FDA.GOV/COMPANIONDIAGNOSTICS.

2.2 Recommended Dosage
The recommended starting dose of IDHIFA is 100 mg taken orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.

Do not split or crush IDHIFA tablets. Administer IDHIFA tablets orally about the same time each day. If a dose of IDHIFA is vomited, missed, or not taken at the usual time, administer the dose as soon as possible on the same day, and return to the normal schedule the following day.

2.3 Monitoring and Dosage Modifications for Toxicities
See package insert: [Drug information  /  PDF]  


HOW SUPPLIED:
16.1 How Supplied
50-mg tablet: Pale yellow to yellow oval-shaped film-coated tablet debossed “ENA” on one side and “50” on the other side.

30-count bottles of 50-mg tablets with a desiccant canister (NDC 59572-705-30)
100-mg tablet: Pale yellow to yellow capsule-shaped film-coated tablet debossed “ENA” on one side and “100” on the other side.

30-count bottles of 100-mg tablets with a desiccant canister (NDC 59572-710-30)
16.2 Storage
Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Store in the original bottle (with a desiccant canister) to protect from moisture.




MAVYRET ™ (glecaprevir and pibrentasvir) tablets  top of page

Drug UPDATESMAVYRET ™ (glecaprevir and pibrentasvir) tablets
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
BOXED WARNING
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1)].

Initial U.S. Approval:  2017

Mechanism of Action:
Glecaprevir
Glecaprevir is an inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication. In a biochemical assay, glecaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1a, 1b, 2a, 2b, 3a, 4a, 5a, and 6a with IC50 values ranging from 3.5 to 11.3 nM.

Pibrentasvir
Pibrentasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.

Antiviral Activity
In HCV replicon assays, glecaprevir had median EC50 values of 0.08-4.6 nM against laboratory and clinical isolates from subtypes 1a, 1b, 2a, 2b, 3a, 4a, 4d, 5a, and 6a. Pibrentasvir had median EC50 values of 0.5-4.3 pM against laboratory and clinical isolates from subtypes 1a, 1b, 2a, 2b, 3a, 4a, 4b, 4d, 5a, 6a, 6e and 6p.

Combination Antiviral Activity
Evaluation of combination of glecaprevir and pibrentasvir showed no antagonism in antiviral activity in HCV genotype 1 replicon cell culture assays.

INDICATIONS AND USAGE:
MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

DOSAGE AND ADMINISTRATION:
2.1 Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with MAVYRET [see Warnings and Precautions (5.1)].

2.2 Recommended Dosage in Adults
MAVYRET is a fixed-dose combination product containing glecaprevir 100 mg and pibrentasvir 40 mg in each tablet.

The recommended oral dosage of MAVYRET is three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken once daily with food [see Clinical Pharmacology (12.3)].

Tables 1 and 2 provide the recommended MAVYRET treatment duration based on the patient population in HCV mono-infected and HCV/HIV-1 co-infected patients with compensated liver disease (with or without cirrhosis) and with or without renal impairment including patients receiving dialysis.

Table 1. Recommended Duration for Treatment-Naïve Patients
See package insert: [Drug information  /  PDF]  


HOW SUPPLIED:
MAVYRET is dispensed in a 4-week (monthly) or an 8-week carton. Each weekly carton contains seven daily dose wallets. Each monthly carton contains four weekly cartons. Each 8-week carton contains 2 monthly cartons. Each child resistant daily dose wallet contains three 100 mg/40 mg glecaprevir/pibrentasvir tablets. MAVYRET tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “NXT” on one side.

The NDC numbers are:

4-Week Carton: 0074-2625-28
8-Week Carton: 0074-2625-56
Store at or below 30°C (86°F).


NERLYNX ™ (neratinib) tablets  top of page

Drug UPDATESNERLYNX ™ (neratinib) tablets
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
Neratinib is a kinase inhibitor that irreversibly binds to Epidermal Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4. In vitro, neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2 and HER4 in vitro. In vivo, oral administration of neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.

INDICATIONS AND USAGE:
NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab based therapy [see Clinical Studies (14)].

DOSAGE AND ADMINISTRATION:
Complex dosing - see package insert:  [Drug information  /  PDF

HOW SUPPLIED:
NERLYNX 40 mg film-coated tablets are red, oval shaped and debossed with ‘W104’ on one side and plain on the other side.

NERLYNX is available in:


Bottles of 180 tablets: NDC 70437-240-18

Bottles of 126 tablets: NDC 70437-240-26
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59–86°F) [see USP Controlled Room Temperature].


VOSEVI™ (sofosbuvir, velpatasvir, and voxilaprevir) tablets  top of page

Drug UPDATESVOSEVI™ (sofosbuvir, velpatasvir, and voxilaprevir) tablets, for oral use

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

BOXED WARNING
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VOSEVI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals (DAA) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated

Initial U.S. Approval:  2017

Mechanism of Action:
Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a, and 4a with an IC50 value ranging from 0.36 to 3.3 µM. GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.

Velpatasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action.

Voxilaprevir is a noncovalent, reversible inhibitor of the NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication. In a biochemical inhibition assay, voxilaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1b and 3a with Ki values of 38 and 66 pM, respectively.



INDICATIONS AND USAGE:
VOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see DOSAGE AND ADMINISTRATION (2.2) and CLINICAL STUDIES (14)]:

>genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
>genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
            Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.


DOSAGE AND ADMINISTRATION:
2.1 Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VOSEVI [see WARNINGS AND PRECAUTIONS (5.1)].

2.2 Recommended Dosage
The recommended dosage of VOSEVI is one tablet, taken orally, once daily with food [see CLINICAL PHARMACOLOGY (12.3)]. One tablet of VOSEVI contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir. Table 1 shows the recommended treatment regimen and duration based on patient population.

Table 1 Recommended Treatment Regimen and Duration in Adults Without Cirrhosis or With Compensated Cirrhosis (Child-Pugh A)
See package insert - [Drug information  /  PDF]  

2.3 No Dosage Recommendations in Severe Renal Impairment and End Stage Renal Disease
No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD), due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].

2.4 Moderate or Severe Hepatic Impairment
VOSEVI is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to higher exposures of voxilaprevir in these patients [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].


HOW SUPPLIED:
Each VOSEVI tablet contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir. The tablets are beige, capsule-shaped, film-coated, and debossed with "GSI" on one side and "Figure" on the other side. Each bottle contains 28 tablets (NDC 61958-2401-1), polyester coil, silica gel desiccant, and is closed with a child-resistant closure.

Store below 30 °C (86 °F). Dispense only in original container.


HAEGARDA ® (C1 Esterase Inhibitor Subcutaneous [Human])   top of page

Drug UPDATESHAEGARDA ® (C1 Esterase Inhibitor Subcutaneous [Human])
For Subcutaneous Injection, Freeze-Dried Powder for Reconstitution

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
C1-INH is a normal constituent of human plasma and belongs to the group of serine protease inhibitors (serpins) that includes antithrombin III, alpha1-protease inhibitor, alpha2-antiplasmin, and heparin cofactor II. As with the other inhibitors in this group, C1-INH has an important inhibiting potential on several of the major human cascade systems, including the complement, fibrinolytic and coagulation systems. Regulation of these systems is performed through the formation of complexes between the protease and the inhibitor, resulting in inactivation of both and consumption of the C1-INH.

C1-INH, which is usually activated during the inflammatory process, inactivates its substrate by covalently binding to the reactive site. C1-INH is the only known inhibitor for the C1r and C1s subcomponents of complement component 1 (C1), coagulation factor XIIa, and plasma kallikrein. Additionally, C1-INH is the main inhibitor for coagulation factor XIa of the intrinsic coagulation cascade.

HAE patients have absence or low levels of endogenous or functional C1-INH. Although the events that cause attacks of angioedema in HAE patients are not well defined, it has been postulated that increased vascular permeability and the clinical manifestation of HAE attacks may be primarily mediated through contact system activation. Suppression of contact system activation by C1-INH through the inactivation of plasma kallikrein and factor XIIa is thought to modulate this vascular permeability by preventing the generation of bradykinin. Administration of HAEGARDA replaces the missing or malfunctioning C1-INH protein in patients with HAE.

INDICATIONS AND USAGE:
HAEGARDA is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

DOSAGE AND ADMINISTRATION:
After reconstitution, for subcutaneous use only.

HAEGARDA is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer HAEGARDA.

HAEGARDA is provided as a freeze-dried powder for reconstitution with Sterile Water for Injection, USP.

2.1 Preparation and Handling
Check the expiration date on the product vial label. Do not use beyond the expiration date.
Work on a clean surface and wash hands before performing the following procedures.
Prepare and administer using aseptic techniques [see DOSAGE AND ADMINISTRATION (2.2)].
Use a silicone-free syringe for reconstitution and administration.
Each vial of HAEGARDA is for single-use only. Promptly use the reconstituted solution. The solution must be used within 8 hours. Discard partially used vials. HAEGARDA contains no preservative.
Do not freeze the reconstituted solution.

2.2 Reconstitution and Administration
Use either the Mix2Vial® transfer set provided with HAEGARDA or a commercially available double-ended needle and vented filter spike [see HOW SUPPLIED/STORAGE AND HANDLING (16)].

Reconstitution
The procedures below are provided as general guidelines for the reconstitution and administration of HAEGARDA.

Table 1. HAEGARDA Reconstitution Instructions
See package insert:
[Drug information  /  PDF

Administration
For subcutaneous injection only.
Train the patient or caregiver on how to self-administer HAEGARDA .
Do not mix HAEGARDA with other medicinal products.
Visually inspect the final solution for particles and discoloration prior to administration, and whenever solution and container permit. Do not use if particles or discoloration is observed.
Attach the syringe containing the reconstituted HAEGARDA solution to a hypodermic needle or subcutaneous infusion set and administer by subcutaneous injection. Adapt the rate of administration to the comfort level of the patient.
Inject in the abdominal area or other subcutaneous injection sites. Rotate injection sites so that the same site is not used repeatedly.
Administer HAEGARDA at room temperature and within 8 hours after reconstitution. Following administration, discard any unused solution and all administration equipment in an appropriate manner as per local requirements.

HOW SUPPLIED:
HAEGARDA is supplied in a kit containing a lyophilized powder in a single-use vial.

HAEGARDA is packaged with Sterile Water for Injection, USP (4 mL for reconstitution of 2000 IU or 6 mL for reconstitution of 3000 IU) and one Mix2Vial filter transfer set. Not made with natural rubber latex.

Nominal Strength Fill Size Color Indicator Kit NDC
2000 IU Fuschia 63833-828-02
3000 IU Yellow 63833-829-02

Storage and Handling:
When stored at temperatures up to 30°C (86°F), HAEGARDA is stable for the period indicated by the expiration date on the carton and vial label.
Keep HAEGARDA in its original carton until ready to use.
Do not freeze.
Protect from light.

KEVZARA ® (sarilumab) injection, for subcutaneous use   top of page

Drug UPDATESKEVZARA ® (sarilumab) injection, for subcutaneous use

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

BOXED WARNING
WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.1)]. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avoid use of KEVZARA in patients with an active infection.

Reported infections include:

Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA use.
Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral and other infections due to opportunistic pathogens.
Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled.

Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection.

Initial U.S. Approval:  2017

Mechanism of Action:
Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.


INDICATIONS AND USAGE:
KEVZARA® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

DOSAGE AND ADMINISTRATION:
2.1 Recommended Dosage
KEVZARA may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.

The recommended dosage of KEVZARA is 200 mg once every two weeks given as a subcutaneous injection.

Reduce dose to 150 mg once every two weeks for management of neutropenia, thrombocytopenia and elevated liver enzymes [see DOSAGE AND ADMINISTRATION (2.4), WARNINGS AND PRECAUTIONS (5.2) and ADVERSE REACTIONS (6.1)].

2.2 General Considerations for Administration
KEVZARA initiation is not recommended in patients with an absolute neutrophil count (ANC) less than 2000 per mm3, platelet count less than 150,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN) [see DOSAGE AND ADMINISTRATION (2.4) and WARNINGS AND PRECAUTIONS (5.2)].
Prior to initiating KEVZARA, test patients for latent tuberculosis (TB). If positive, consider treating for TB prior to KEVZARA use [see WARNINGS AND PRECAUTIONS (5.1)].
Avoid using KEVZARA with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection. The concurrent use of KEVZARA with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied.
Avoid KEVZARA use in patients with active infections [see WARNINGS AND PRECAUTIONS (5.1)].
2.3 Important Administration Instructions
KEVZARA is intended for use under the guidance of a healthcare professional. A patient may self-inject KEVZARA or the patient's caregiver may administer KEVZARA. Provide proper training to patients and/or caregivers on the preparation and administration of KEVZARA prior to use according to the Instructions for Use (IFU).
Allow the pre-filled syringe to sit at room temperature for 30 minutes prior to subcutaneous injection. Do not warm KEVZARA in any other way.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. KEVZARA solution should be clear and colorless to pale yellow. Do not use if the solution is cloudy, discolored or contains particles, or if any part of the pre-filled syringe appears to be damaged.
Instruct patients to inject the full amount in the syringe (1.14 mL), which provides 200 mg or 150 mg of KEVZARA, according to the directions provided in the IFU.
Rotate injection sites with each injection. Do not inject into skin that is tender, damaged, or has bruises or scars.
2.4 Dosage Modifications for Laboratory Abnormalities or Serious Infection
If a patient develops a serious infection, hold treatment with KEVZARA until the infection is controlled.

Modify dosage in case of neutropenia, thrombocytopenia or liver enzyme elevations (see TABLE 1). For treatment initiation criteria, see [DOSAGE AND ADMINISTRATION (2.2)].

Table 1: KEVZARA Dosage Modification for Neutropenia, Thrombocytopenia, or Elevated Liver Enzymes
See package insert - Drug information  /  PDF

HOW SUPPLIED:
KEVZARA (sarilumab) injection is supplied as a colorless to pale yellow solution in a single-dose pre-filled syringe.

Strength Package Size NDC Number
150 mg/1.14 mL 2 syringes per pack 0024-5908-01
200 mg/1.14 mL 2 syringes per pack 0024-5910-01
Storage and Stability

Refrigerate at 36°F to 46°F (2°C to 8°C) in original carton to protect from light. Do not freeze. Do not shake.

If needed, patients/caregivers may store KEVZARA at room temperature up to 77°F (25°C) up to 14 days in the outer carton. Do not store above 77°F (25°C). After removal from the refrigerator, use KEVZARA within 14 days or discard.




TREMFYA ™ (guselkumab) injection  top of page

Drug UPDATESTREMFYA ™ (guselkumab) injection
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.


INDICATIONS AND USAGE:
TREMFYA™ is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

DOSAGE AND ADMINISTRATION:
2.1 Dosage
TREMFYA is administered by subcutaneous injection. The recommended dose is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.

2.2 Tuberculosis Assessment Prior to Initiation of TREMFYA
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA [see WARNINGS AND PRECAUTIONS (5.2)].

2.3 Important Administration Instructions
Administer TREMFYA subcutaneously. Each prefilled syringe is for single-dose only. Instruct patients to inject the full amount (1 mL), which provides 100 mg of TREMFYA.

Do not inject TREMFYA into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis [see INSTRUCTIONS FOR USE].

TREMFYA is intended for use under the guidance and supervision of a physician. TREMFYA may be administered by a health care professional, or a patient may self-inject after proper training in subcutaneous injection technique.

The TREMFYA Instructions for Use contains more detailed patient instructions on the preparation and administration of TREMFYA [see INSTRUCTIONS FOR USE].

2.4 Preparation for Use of TREMFYA Prefilled Syringe
Before injection, remove TREMFYA prefilled syringe from the refrigerator and allow TREMFYA to reach room temperature (30 minutes) without removing the needle cap.

Inspect TREMFYA visually for particulate matter and discoloration prior to administration. TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. Do not use if the liquid contains large particles, is discolored or cloudy. TREMFYA does not contain preservatives; therefore, discard any unused product remaining in the prefilled syringe.

HOW SUPPLIED:
16.1 How supplied
TREMFYA (guselkumab) Injection is a clear and colorless to light yellow solution that may contain small translucent particles. TREMFYA is supplied as a single-dose 100 mg/mL prefilled syringe:

NDC CODE: 57894-640-01
16.2 Storage and Handling
TREMFYA is sterile and preservative-free. Discard any unused portion.

Store in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF)
Store in original carton until time of use
Protect from light until use.
Do not freeze.
Do not shake



CORPHEDRA ™ (ephedrine sulfate injection, USP) for intravenous use   top of page

Drug UPDATESCORPHEDRA ™ (ephedrine sulfate injection, USP) for intravenous use

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and ß­ adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Indirect adrenergic stimulation is caused by norepinephrine release from sympathetic nerves.

INDICATIONS AND USAGE:
CORPHEDRA is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

DOSAGE AND ADMINISTRATION:
2.1 General Dosage and Administration Instructions
CORPHEDRA must be diluted before administration to achieve the desired concentration as an intravenous bolus or intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is colored or cloudy, or if it contains particulate matter.

2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia
The recommended dosage for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 to 10 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 50 mg.

Adjust dosage according to the blood pressure goal (i.e., titrate to effect).

2.3 Preparation of a 5 mg/mL Solution for Bolus Intravenous Administration
For bolus intravenous administration, prepare a solution containing a final concentration of 5 mg/mL of ephedrine sulfate injection.

Withdraw 50 mg (1 mL of 50 mg/mL) of ephedrine sulfate injection and dilute with 9 mL of 5% Dextrose Injection or Sodium Chloride Injection.
Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus intravenous administration.


HOW SUPPLIED:
CORPHEDRA (ephedrine sulfate injection), 50 mg/mL, is supplied as follows:

42023-196-01
50 mg/mL
1 mL clear glass vial; for single use (supplied in packages of 25)

Vial stoppers are not manufactured with natural rubber latex.

Store CORPHEDRA, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. For single use only. Discard unused portion.




MYDAYIS (mixed salts of a single-entity amphetamine product) extended-release  top of page

Drug UPDATESMYDAYIS (mixed salts of a single-entity amphetamine product) extended-release capsules, for oral use, CII
Initial U.S. Approval: 2001

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
BOXED WARNING
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including MYDAYIS, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see WARNINGS AND PRECAUTIONS (5.1, 9.3), and DRUG ABUSE AND DEPENDENCE (9.2, 9.3)].

Initial U.S. Approval:  2001

Mechanism of Action:
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.

INDICATIONS AND USAGE:
MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see CLINICAL STUDIES (14)].

Limitations of Use
Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see USE IN SPECIFIC POPULATIONS (8.4)].

DOSAGE AND ADMINISTRATION:
2.1 Important Information Prior to Initiating Treatment
Prior to initiating treatment with MYDAYIS, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS AND PRECAUTIONS (5.2)].

Assess the risk of abuse, prior to prescribing and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for MYDAYIS use [see WARNINGS AND PRECAUTIONS (5.1), DRUG ABUSE AND DEPENDENCE (9)].

2.2 General Instructions for Use
Because the effects of MYDAYIS may last up to 16 hours and there is potential for insomnia, administer once daily in the morning upon awakening. In the event of a missed dose, do not administer later in the day. Do not administer additional medication to make up for the missed dose [see ADVERSE REACTIONS (6.1), CLINICAL STUDIES (14)].

Pharmacological treatment of ADHD may be needed for an extended period. Periodically re-evaluate the long-term use of MYDAYIS and adjust dosage as needed.

2.3 Administration Instructions:
Administer MYDAYIS orally with or without food. Advise patients to take MYDAYIS consistently either with food or without food [see CLINICAL PHARMACOLOGY (12.3)].

MYDAYIS may be administered in one of the following ways:

Swallow MYDAYIS capsules whole, or
Open capsule and sprinkle the entire contents over a spoonful of applesauce. The sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the sprinkled applesauce in its entirety without chewing.
The dose of a single capsule should not be divided.
2.4 Dosing Information
Adult Use (18 to 55 years)

The recommended starting dose of MYDAYIS is 12.5 mg once daily in the morning upon awakening. Initial doses of 25 mg once daily may be considered for some patients. Dosage may be adjusted in increments of 12.5 mg no sooner than weekly, up to a maximum dose of 50 mg once daily, based on the therapeutic needs and response of the patient. Doses above 50 mg daily have shown no additional clinically meaningful benefit.

Pediatric Use (13 to 17 years)
The recommended starting dose is 12.5 mg once daily in the morning upon awakening. Dosage may be adjusted in increments of 12.5 mg no sooner than weekly, up to a recommended maximum dose of 25 mg once daily. The dose should be individualized according to the needs and response of the patient. Doses higher than 25 mg have not been evaluated in clinical trials in pediatric patients.

2.5 Dosage Modifications due to Drug Interactions:
Agents that alter gastrointestinal and urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust MYDAYIS dosage accordingly [see DRUG INTERACTIONS (7.1)].

2.6 Dosage in Patients with Renal Impairment:
In adult patients with severe renal impairment (GFR between 15 to < 30 mL/min/1.73 m2), the recommended starting dose of MYDAYIS is 12.5 mg daily with a maximum recommended dose of 25 mg daily. MYDAYIS is not recommended for use in patients with end stage renal disease (ESRD < 15 ml/min/1.73 m2). In pediatric patients (13 to 17 years) with severe renal impairment, the maximum dose is 12.5 mg, if tolerated [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].

2.7 Switching from other Amphetamine Products:
For patients switching from another medication or any other amphetamine products, discontinue that treatment, and titrate with MYDAYIS using the titration schedule [see DOSAGE AND ADMINISTRATION (2.4)].

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see WARNINGS AND PRECAUTIONS (5.9), DESCRIPTION (11), CLINICAL PHARMACOLOGY (12.3)].

HOW SUPPLIED:
MYDAYIS Extended-Release capsules are available as:

12.5 mg: Green body/green cap (imprinted with black SHIRE 465 and 12.5 mg), bottles of 100, NDC 54092-468-01
25 mg: Ivory body/green cap (imprinted with black SHIRE 465 and 25 mg), bottles of 100, NDC 54092-471-01
37.5 mg: Ivory body/caramel cap (imprinted with black SHIRE 465 and 37.5 mg), bottles of 100, NDC 54092-474-01
50 mg: Ivory body/purple cap (imprinted with black SHIRE 465 and 50 mg), bottles of 100, NDC 54092-477-01
Storage and Handling

Dispense in a tight, light-resistant container as defined in the USP.

Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired MYDAYIS by a medicine take-back program.

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired MYDAYIS at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix MYDAYIS with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard MYDAYIS in the household trash.


RHOFADE™ (oxymetazoline hydrochloride) cream, for topical use   top of page

Drug UPDATESRHOFADE™ (oxymetazoline hydrochloride) cream, for topical use

[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
Oxymetazoline is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.

INDICATIONS AND USAGE:
RHOFADE™ cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

DOSAGE AND ADMINISTRATION:
For topical use only. RHOFADE is not for oral, ophthalmic, or intravaginal use.

Prime the RHOFADE pump before using for the first time. To do so, with the pump in the upright position, repeatedly depress the actuator until cream is dispensed and then pump three times. Discard the cream from priming actuations. It is only necessary to prime the pump before the first dose.

RHOFADE tubes do not require priming.

Apply a pea-sized amount of RHOFADE cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands immediately after applying RHOFADE cream.

HOW SUPPLIED:
RHOFADE (oxymetazoline hydrochloride) cream, 1%, is a white to off-white cream. The product is available in a laminated tube and an airless pump polypropylene bottle in the following packaging configurations, each with a child-resistant closure:

NDC 0023-5300-30 30 gram tube

NDC 0023-5300-60 60 gram tube

NDC 0023-5300-35 30 gram pump

NDC 0023-5300-65 60 gram pump

Storage: Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

®  top of page



DISCLAIMER top of page

Disclaimer - Please see package insert if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer   |   <BACK
Medical Calculators - A thru Z
Lab Values - A thru Z