Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
TPOXX®
(tecovirimat) capsules for oral use
TPOXX (tecovirimat) is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein. TPOXX is available as immediate release capsules containing tecovirimat monohydrate equivalent to 200 mg of tecovirimat for oral administration. The capsules are imprinted in white ink with “SIGA” followed by the SIGA logo followed by “®” on an orange body, and a black cap imprinted in white ink with “ST-246®.” The capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell is composed of gelatin, FD&C blue #1, FD&C red #3, FD&C yellow #6, and titanium dioxide.
Tecovirimat monohydrate is a white to off-white crystalline solid with the chemical name Benzamide, N-[(3aR,4R,4aR,5aS,6S,6aS)-3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6 ethenocycloprop[f]isoindol-2(1H)-yl]-4-(trifluoromethyl), rel-(monohydrate). The chemical formula is C19H15F3N2O3· H2O representing a molecular weight of 394.35 g/moL. The molecular structure is as follows:
 |
Tecovirimat monohydrate is practically insoluble in water and across the pH range of 2.0-6.5 (< 0.1 mg/mL).
TPOXX® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg.
The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical [see Clinical Studies].
TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.
The recommended dosage of TPOXX in adults and pediatric patients weighing at least 40 kg is 600 mg (three 200 mg capsules) taken twice daily orally for 14 days. TPOXX should be taken within 30 minutes after a full meal of moderate or high fat [see CLINICAL PHARMACOLOGY].
The recommended dosage for pediatric patients is based on weight starting at 13 kg as shown in Table 1. The dose should be given twice daily orally for 14 days and should be taken within 30 minutes after a full meal of moderate or high fat [see CLINICAL PHARMACOLOGY].
TPOXX capsules can be administered by carefully opening the capsule and mixing the entire contents in 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., apple sauce, yogurt). The entire mixture should be administered within 30 minutes of its preparation.
Table 1: Recommended Pediatric and Adult Dosage and Preparation Instructions
| Body Weight | Dosage | Number of Capsules | Drug-Food Preparation |
| 13 kg to less than 25 kg | 200 mg twice daily | Contents of 1 Capsule twice daily | Mix 1 capsule of TPOXX with 30 mL of liquid or soft food. Administer the whole mixture. |
| 25 kg to less than 40 kg | 400 mg twice daily | Contents of 2 Capsules twice daily | Mix 2 capsules of TPOXX with 30 mL of liquid or soft food. Administer the whole mixture. |
| 40 kg and above | 600 mg twice daily | Contents of 3 Capsules twice daily | Mix 3 capsules of TPOXX with 30 mL of liquid or soft food. Administer the whole mixture. |
TPOXX capsules are hard gelatin with an opaque orange body imprinted in white ink with “SIGA” followed by the SIGA logo followed by the “®”, and an opaque black cap imprinted in white ink with “ST-246®”, containing white to off-white powder. Each capsule contains 200 mg of tecovirimat.
Each TPOXX capsule contains 200 mg of tecovirimat. TPOXX capsules are hard gelatin with an opaque orange body imprinted in white ink with “SIGA” followed by the SIGA logo followed by “®”, and an opaque black cap imprinted in white ink with “ST-246®”, containing white to off-white powder. Each bottle contains 42 capsules (NDC 50072-200-42) with an induction seal and child-resistant cap.
Store capsules in the original bottle at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Manufactured by: Catalent Pharma Solutions, 1100 Enterprise Drive, Winchester, KY 40391. Revised: July 2018
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TPOXX has not been studied in patients with smallpox disease.
The safety of TPOXX was evaluated in 359 healthy adult subjects ages 18-79 years in a Phase 3 clinical trial. Of the subjects who received at least one 600 mg dose of TPOXX, 59% were female, 69% were White, 28% were Black/African American, 1% were Asian, and 12% were Hispanic or Latino. Ten percent of the subjects who participated in the study were age 65 or older. Of these 359 subjects, 336 subjects received at least 23 of 28 doses of 600 mg TPOXX in a twice daily regimen for 14 days.
The most frequently reported adverse reactions were headache and nausea. Adverse reactions that occurred in at least 2% of subjects in the TPOXX treatment group are shown in Table 2.
Table 2: Adverse Reactions Reported in ≥ 2% of Healthy Adult Subjects Receiving at Least One Dose of TPOXX 600 mg
| Adverse Reaction | TPOXX 600 mg N = 359 (%) |
Placebo N = 90 (%) |
| Headache | 12 | 8 |
| Nausea | 5 | 4 |
| Abdominal paina | 2 | 1 |
| Vomiting | 2 | 0 |
| a Includes abdominal pain, abdominal pain upper, abdominal distension, abdominal discomfort, abdominal pain lower, epigastric pain | ||
Six subjects (2%) had their treatment with TPOXX discontinued due to adverse reactions. Each of these subject’s adverse reactions (with severity) is listed below:
Clinically significant adverse reactions that were reported in < 2% of subjects exposed to TPOXX and at rates higher than subjects who received placebo are listed below:
Tecovirimat is a weak inducer of cytochrome P450 (CYP)3A and a weak inhibitor of CYP2C8 and CYP2C19. However, the effects are not expected to be clinically relevant for most substrates of those enzymes based on the magnitude of interactions and the duration of treatment of TPOXX. See Table 3 for clinical recommendations for select sensitive substrates.
Table 3 provides a listing of established or significant drug interactions [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Table 3: Significant Drug Interactions
| Concomitant Drug Class: Drug Name |
Effect on Concentrationa | Clinical Effect/Recommendation |
| Blood Glucose-Lowering Agent: | ||
| Repaglinideb | ↑repaglinide | Monitor blood glucose and monitor for hypoglycemic symptoms in patients when TPOXX is co-administered with repaglinide [see WARNINGS AND PRECAUTIONS]. |
| CNS Depressant: | ||
| Midazolamb | ↓midazolam | Monitor for effectiveness of midazolam. |
|
a ↓ = decrease, ↑ = increase b These interactions have been studied in healthy adults. |
||
Based on a drug interaction study, no clinically significant drug interactions have been observed when TPOXX is co-administered with bupropion, flurbiprofen, or omeprazole [see CLINICAL PHARMACOLOGY].
No vaccine-drug interaction studies have been performed in human subjects. Some animal studies have indicated that co-administration of TPOXX at the same time as live smallpox vaccine (vaccinia virus) may reduce the immune response to the vaccine. The clinical impact of this interaction on vaccine efficacy is unknown.
Included as part of the "PRECAUTIONS" Section
Co-administration of repaglinide and tecovirimat may cause mild to moderate hypoglycemia. Monitor blood glucose and monitor for hypoglycemic symptoms when administering TPOXX with repaglinide [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
In a drug interaction study, 10 of 30 healthy subjects experienced mild (6 subjects) or moderate (4 subjects) hypoglycemia following co-administration of repaglinide (2 mg) and TPOXX. Symptoms resolved in all subjects after intake of food and/or oral glucose.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Inform patients that the efficacy of TPOXX is based solely on efficacy studies demonstrating a survival benefit in animals and that the effectiveness of TPOXX has not been tested in humans with smallpox disease [see Clinical Studies].
Advise patients to take TPOXX as directed within 30 minutes of eating a full meal of moderate or high fat [see CLINICAL PHARMACOLOGY]. Inform patients to take TPOXX for the entire duration without missing or skipping a dose [see DOSAGE AND ADMINISTRATION].
Inform patients that TPOXX may interact with other drugs. Advise patients to report to their healthcare provider the use of other prescription drugs. Co-administration of TPOXX with repaglinide may cause hypoglycemia [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Carcinogenicity studies have not been conducted with tecovirimat.
Tecovirimat was not genotoxic in in vitro or in vivo assays, including a bacterial reverse mutation assay, a mammalian mutagenicity assay in mouse lymphoma L5178Y/TK± cells, and in an in vivo mouse micronucleus study.
In a fertility and early embryonic development study in mice, no effects of tecovirimat on female fertility were observed at tecovirimat exposures (AUC) approximately 24 times higher than human exposure at the RHD. In male mice, decreased male fertility associated with testicular toxicity (increased percent abnormal sperm and decreased sperm motility) was observed at 1,000 mg/kg/day (approximately 24 times the human exposure at the RHD).
No adequate and well-controlled studies in pregnant women were conducted; therefore there are no human data to establish the presence or absence of TPOXX associated risk.
In animal reproduction studies, no embryofetal developmental toxicity was observed in mice during the period of organogenesis at tecovirimat exposures (area under the curve [AUC]) up to 23 times higher than human exposure at the recommended human dose (RHD). In rabbits, no embryofetal developmental toxicity was observed during organogenesis at tecovirimat exposures (AUC) less than human exposures at the RHD. In a mouse pre-/post-natal development study, no toxicities were observed at maternal tecovirimat exposures up to 24 times higher than human exposure at the RHD (see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Animal Data:
Tecovirimat was administered orally to pregnant mice at doses up to 1,000 mg/kg/day from gestation Days 6-15. No embryofetal toxicities were observed at doses up to 1,000 mg/kg/day (approximately 23 times higher than human exposure at the RHD).
Tecovirimat was administered orally to pregnant rabbits at doses up to 100 mg/kg/day from gestation Days 6-19. No embryofetal toxicities were observed at doses up to 100 mg/kg/day (0.4 times the human exposure at the RHD).
In the pre-/post-natal development study, tecovirimat was administered orally to pregnant mice at doses up to 1,000 mg/kg/day from gestation Day 6 to post-natal Day 20. No toxicities were observed at doses up to 1,000 mg/kg/day (approximately 24 times higher than human exposure at the RHD).
There are no data to assess the effect on milk production, the presence of the drug in human milk, and/or the effects on the breastfed child. When administered to lactating mice, tecovirimat was present in the milk (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TPOXX and any potential adverse effects on the breastfed child from TPOXX or from the underlying maternal condition.
Data
In a lactation study at doses up to 1,000 mg/kg/day, mean tecovirimat milk to plasma ratios up to approximately 0.8 were observed at 6 and 24 hours post-dose when administered orally to mice on lactation Day 10 or 11.
There are no data on the effect of tecovirimat on female and male reproductive potential in humans. Decreased fertility due to testicular toxicity was observed in male mice [see Nonclinical Toxicology].
As in adults, the effectiveness of TPOXX in pediatric patients is based solely on efficacy studies in animal models of orthopoxvirus disease. As exposure of healthy pediatric subjects to TPOXX with no potential for direct clinical benefit is not ethical, pharmacokinetic simulation was used to derive dosing regimens that are predicted to provide pediatric patients with exposures comparable to the observed exposure in adults receiving 600 mg twice daily. The dosage for pediatric patients is based on weight [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Clinical studies of TPOXX did not include sufficient numbers of subjects aged 65 and over to determine whether the safety profile of TPOXX is different in this population compared to younger subjects. Of the 359 subjects in the clinical study of TPOXX, 10% (36/359) were ≥ 65 years of age, and 1% (4/359) were ≥ 75 years of age. No alteration of dosing is needed for patients ≥ 65 years of age [see CLINICAL PHARMACOLOGY].
No dosage adjustment is required for patients with mild, moderate or severe renal impairment or patients with end stage renal disease (ESRD) requiring hemodialysis [see CLINICAL PHARMACOLOGY].
No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (Child Pugh Class A, B, or C) [see CLINICAL PHARMACOLOGY].
There is no clinical experience with overdosage of TPOXX. In case of overdosage, monitor patients for any signs or symptoms of adverse effects. Hemodialysis will not significantly remove TPOXX in overdosed patients.
None.
Tecovirimat is an antiviral drug against variola (smallpox) virus [see Microbiology].
TPOXX does not prolong the QT interval to any clinically relevant extent at the anticipated therapeutic exposure.
At the approved recommended dosage, the mean steady-state values of TPOXX AUC0-24hr, Cmax, and Cmin are 28791 hr·ng/mL (CV: 35%), 2106 ng/mL (CV: 33%), and 587 ng/mL (CV: 38%), respectively. Tecovirimat steady-state AUC is achieved by Day 6. Refer to Table 4 for pharmacokinetic parameters of tecovirimat.
Table 4: Pharmacokinetic Properties of Tecovirimat
| Absorption | |
| Tmax (h)a | 4-6 |
| Effect of food (relative to fasting)b | ↑39% |
| Distribution | |
| % Bound to human plasma proteins | 77-82 |
| Blood-to-plasma ratio (drug or drug-related materials) | 0.62-0.90 |
| Volume of distribution (Vz/F, L) | 1030 |
| Metabolism | |
| Metabolic pathwaysc | Hydrolysis, UGT1A1d, UGT1A4 |
| Elimination | |
| Major route of elimination | Metabolism |
| Clearance (CL/F, L/hr) | 31 |
| t1/2 (h)e | 20 |
| % of dose excreted in urinef | 73, predominantly as metabolites |
| % of dose excreted in fecesf | 23, predominantly as tecovirimat |
|
a Value reflects administration of drug with food. b Value refers to mean systemic exposure (AUC24hr). Meal: ~ 600 kcal, ~ 25 g fat. c Tecovirimat is metabolized by hydrolysis of the amide bond and glucuronidation. The following inactive metabolites were detected in plasma: M4 (N-{3,5-dioxo-4-azatetracyclo[5.3.2.0{2,6}.0{8,10}]dodec-11-en-4yl} amine), M5 (3,5 dioxo-4-aminotetracyclo[5.3.2.0{2,6}.0{8,10}]dodec-11-ene), and TFMBA (4 (trifluoromethyl) benzoic acid) d Uridine diphosphate (UDP)-glucuronosyl transferase (UGT) enzymes e t1/2 value refers to mean terminal plasma half-life. f Single dose administration of [14C]-tecovirimat in mass balance study. |
|
Because the effectiveness of TPOXX cannot be tested in humans, a comparison of tecovirimat exposures achieved in healthy human subjects to those observed in animal models of orthopoxvirus infection (nonhuman primates and rabbits infected with monkeypox virus and rabbitpox virus, respectively) in therapeutic efficacy studies was necessary to support the dosage regimen of 600 mg twice daily for treatment of smallpox disease in humans. Humans achieve greater systemic exposure (AUC, Cmax, and Cmin) of tecovirimat following a twice daily dose of 600 mg when compared to the therapeutic exposures in these animal models.
No clinically significant differences in the pharmacokinetics of tecovirimat were observed based on age, sex, ethnicity, renal impairment (based on estimated GFR), or hepatic impairment (Child Pugh Scores A, B or C).
TPOXX pharmacokinetics has not been evaluated in pediatric patients. The recommended pediatric dosing regimen is expected to produce tecovirimat exposures that are comparable to those in adult subjects based on a population pharmacokinetic modeling and simulation approach [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].
The effect of tecovirimat on the exposure of co-administered drugs are shown in Table 5.
Table 5: Drug Interactions – Changes in Pharmacokinetic Parameters for Co-Administered Drug in the Presence of TPOXXa
| Co-Administered Drug | Dose of Co-Administered Drug (mg) | N | Mean Ratio (90% CI) of Co-Administered Drug PK With/Without TPOXX No Effect = 1.00 |
|
| Cmax | AUCinf | |||
| Flurbiprofen + omeprazole + midazolamb | omeprazole 20 single dose | 24 | 1.87 (1.51, 2.31) |
1.73 (1.36, 2.19) |
| midazolam 2 single dose | 0.61 (0.54, 0.68) |
0.68 (0.63, 0.73) |
||
| Repaglinide | 2 single dose | 30 | 1.27 (1.12, 1.44) |
1.29 (1.19, 1.40) |
| Bupropion | 150 single dose | 24 | 0.86 (0.79, 0.93) |
0.84 (0.78, 0.89) |
|
a All interaction studies conducted in healthy volunteers with tecovirimat 600 mg twice daily. b Comparison based on exposures when administered as flurbiprofen + omeprazole + midazolam. |
||||
No pharmacokinetic changes were observed for the following drug when co-administered with tecovirimat: flurbiprofen.
Cytochrome P450 (CYP) Enzymes: Tecovirimat is a weak inhibitor of CYP2C8 and CYP2C19, and a weak inducer of CYP3A4. Tecovirimat is not an inhibitor or an inducer of CYP2B6 or CYP2C9.
CYP Enzymes:
Tecovirimat is not an inhibitor of CYP1A2, CYP2D6, CYP2E1 or CYP3A4, and is not an inducer of CYP1A2. Tecovirimat is not a substrate for CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4.
UGT Enzymes:
Tecovirimat is a substrate of UGT1A1 and UGT1A4.
Transporter Systems:
Tecovirimat inhibited Breast Cancer Resistance Protein (BCRP) in vitro.
Tecovirimat is not an inhibitor of P-glycoprotein (P-gp), organic anion transporting polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3), organic anion transporter 1 (OAT1), OAT3, and organic cation transporter 2 (OCT2). Tecovirimat is not a substrate for P-gp, BCRP, OATP1B1, and OATP1B3.
Tecovirimat targets and inhibits the activity of the orthopoxvirus VP37 protein (encoded by and highly conserved in all members of the orthopoxvirus genus) and blocks its interaction with cellular Rab9 GTPase and TIP47, which prevents the formation of egress-competent enveloped virions necessary for cell-to-cell and long-range dissemination of virus.
In cell culture assays, the effective concentrations of tecovirimat resulting in a 50% reduction in virus-induced cytopathic effect (EC50), were 0.016-0.067 μM, 0.014-0.039 μM, 0.015 μM, and 0.009 μM, for variola, monkeypox, rabbitpox, and vaccinia viruses, respectively. Ranges given for variola and monkeypox viruses are reflective of results from multiple strains assayed.
There are no known instances of naturally occurring tecovirimat resistant orthopoxviruses, although tecovirimat resistance may develop under drug selection. Tecovirimat has a relatively low resistance barrier, and certain amino acid substitutions in the target VP37 protein can confer large reductions in tecovirimat antiviral activity. The possibility of resistance to tecovirimat should be considered in patients who either fail to respond to therapy or who develop recrudescence of disease after an initial period of responsiveness.
Cross Resistance:
There are no other antiviral drugs approved for the treatment of variola (smallpox) virus infection.
In a repeat-dose toxicology study in dogs, convulsions (tonic and clonic) were observed in one animal within 6 hours of a single dose of 300 mg/kg (approximately 4 times higher than the highest observed human exposure at the RHD based on Cmax). Electroencephalography (EEG) findings in this animal were consistent with seizure activity during the observed convulsions. Tremors, which were considered non-adverse, were observed at 100 mg/kg/dose (similar to the highest observed human exposure at the RHD based on Cmax), although no convulsions or EEG findings were observed at this dose.
The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. Therefore, the effectiveness of TPOXX for treatment of smallpox disease was established based on results of adequate and well-controlled animal efficacy studies of non-human primates and rabbits infected with non-variola orthopoxviruses. Survival rates observed in the animal studies may not be predictive of survival rates in clinical practice.
Efficacy studies were conducted in cynomolgus macaques infected with monkeypox virus, and New Zealand white (NZW) rabbits infected with rabbitpox virus. The primary efficacy endpoint for these studies was survival. In non-human primate studies, cynomolgus macaques were lethally challenged intravenously with 5 x 107 plaque-forming units of monkeypox virus; tecovirimat was administered orally once daily at a dose level of 10 mg/kg for 14 days, starting at Day 4, 5 or 6 post-challenge. In rabbit studies, NZW rabbits were lethally challenged intradermally with 1,000 plaque-forming units of rabbitpox virus; tecovirimat was administered orally once daily for 14 days at a dose level of 40 mg/kg, starting at Day 4 post-challenge. The timing of tecovirimat dosing in these studies was intended to assess efficacy when treatment is initiated after animals have developed clinical signs of disease, specifically dermal pox lesions in cynomolgus macaques, and fever in rabbits. Clinical signs of disease were evident in some animals at Day 2-3 post-challenge but were evident in all animals by Day 4 post-challenge. Survival was monitored for 3-6 times the mean time to death for untreated animals in each model.
Treatment with tecovirimat for 14 days resulted in statistically significant improvement in survival relative to placebo, except when given to cynomolgus macaques starting at Day 6 post-challenge (Table 6).
Table 6: Survival Rates in Tecovirimat Treatment Studies in Cynomolgus Macaques and NZW Rabbits Exhibiting Clinical Signs of Orthopoxvirus Disease
| Treatment Initiationa | Survival Percentage (# survived/n) |
p-valueb | Survival Rate Differencec (95% CI)d |
||
| Placebo | Tecovirimat | ||||
| Cynomolgus Macaques | |||||
| Study 1 | Day 4 | 0% (0/7) | 80% (4/5) | 0.0038 | 80% (20.8%, 99.5%) |
| Study 2 | Day 4 | 0% (0/6) | 100% (6/6) | 0.0002 | 100% (47.1%, 100%) |
| Study 3 | Day 4 | 0% (0/3) | 83% (5/6) | 0.0151 | 83% (7.5%, 99.6%) |
| Day 5 | 83% (5/6) | 0.0151 | 83% (7.5%, 99.6%) |
||
| Day 6 | 50% (3/6) | 0.1231 | 50% (-28.3%, 90.2%) |
||
| NZW Rabbits | |||||
| Study 4 | Day 4 | 0% (0/10) | 90% (9/10) | < 0.0001 | 90% (50.3%, 99.8%) |
| Study 5 | Day 4 | NAe | 88% (7/8) | NA | NA |
|
a Day post-challenge tecovirimat treatment was initiated b p-value is from 1-sided Boschloo Test (with Berger-Boos modification of gamma = 0.000001) compared to placebo c Survival percentage in tecovirimat treated animals minus survival percentage in placebo treated animals d Exact 95% confidence interval based on the score statistic of difference in survival rates e A placebo control group was not included in this study. KEY: NA = Not Applicable |
|||||
TPOXX
(Te-Pox or Tee-pahx)
(tecovirimat) Capsules
What is TPOXX?
TPOXX is a prescription medicine used to treat smallpox disease caused by a type of virus called variola virus in adults and children who weigh at least 13 kg.
Before taking TPOXX, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TPOXX. Keep a list of your medicines to show your healthcare provider and pharmacist.
How should I take TPOXX?
What are the possible side effects of TPOXX?
TPOXX may cause serious side effects, including:
The most common side effects of TPOXX include:
These are not all the possible side effects of TPOXX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store TPOXX?
Keep TPOXX and all other medicines out of the reach of children.
General information about the safe and effective use of TPOXX.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TPOXX for a condition for which it was not prescribed. Do not give TPOXX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TPOXX that is written for health professionals.
What are the ingredients in TPOXX?
Active ingredient: tecovirimat
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell is made of gelatin, FD&C blue #1, FD&C red #3, FD&C yellow #6, and titanium dioxide.
Instructions For Use
TPOXX
(Te-Pox or Tee-pahx)
(tecovirimat)
capsules
Read this Instructions for Use before taking TPOXX and follow the steps below to prepare and give a dose of TPOXX to adults or children who have trouble swallowing TPOXX capsules.
Step 1: Gather the supplies you need to prepare a dose of TPOXX:
Step 2: Find the weight of the person taking the medicine on the TPOXX Dosing Table.
Step 3: Find the prescribed dose in the same row as the weight of the person taking the medicine on the TPOXX Dosing Table below.
Step 4: Find the amount of liquid or soft food needed in the same row as the weight of the person taking the medicine on the TPOXX Dosing Table below.
Step 5: Find the number of TPOXX capsules needed in the same row as the weight of the person taking the medicine on the TPOXX Dosing Table below.
Step 6: Hold the TPOXX capsule in a sideways (horizontal) position directly over the bowl to make sure none of the medicine is lost.
Step 7: Use the tablespoon to mix together the capsule contents and the liquid or soft food.
Step 8: The food and medicine mixture must be taken within 30 minutes after a meal containing approximately 25 grams of fat AND within 30 minutes after mixing it.
TPOXX Dosing Table
| Body Weight | Prescribed Dose | Amount of Liquid or Soft Food | Number of Capsules | Food and Medicine Mixture Instructions |
| 13 kg to less than 25 kg | 200 mg | 2 tablespoons | 1 TPOXX capsule | Mix entire contents of 1 TPOXX capsule with 2 tablespoons of liquid or soft food. |
| 25 kg to less than 40 kg | 400 mg | 2 tablespoons | 2 TPOXX capsules | Mix entire contents of 2 TPOXX capsules with 2 tablespoons of liquid or soft food. |
| 40 kg and above | 600 mg | 2 tablespoons | 3 TPOXX capsules | Mix entire contents of 3 TPOXX capsules with 2 tablespoons of liquid or soft food. |
Keep TPOXX and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
