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What is Purixan?
Purixan is a prescription medicine used along with other medicines to treat people with acute lymphoblastic leukemia (ALL).
What are the possible side effects of Purixan?
Purixan can cause serious side effects, including:
Less common side effects of Purixan include: loss of appetite, nausea, vomiting, diarrhea, generally do not feel well, and rash.
Low blood sugar (hypoglycemia) can happen, especially in children under six years of age.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Purixan.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Mercaptopurine, a nucleoside metabolic inhibitor, known chemically as 1,7-dihydro-6H-purine-6-thione monohydrate, is an analogue of the purine bases adenine and hypoxanthine. Mercaptopurine is a yellow, odorless or practically odorless, crystalline powder with a molecular formula of C5H4N4S·H2O and a molecular weight of 170.20 as a monohydrate. The structural formula is:
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PURIXAN (mercaptopurine) oral suspension is supplied for oral administration and contains 2000 mg/100 mL (20 mg/mL) of mercaptopurine. The suspension also contains the following inactive ingredients: xanthan gum, aspartame, concentrated raspberry juice, sucrose, ethyl parahydroxybenzoate sodium, methyl parahydroxybenzoate sodium, potassium sorbate, sodium hydroxide and purified water. PURIXAN is a pink to brown viscous suspension. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided.
PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
The recommended starting dose of PURIXAN is 1.5 to 2.5 mg/kg (50 to 75 mg/m2) orally once daily as part of combination chemotherapy maintenance regimen. Take PURIXAN either consistently with or without food.
After initiating PURIXAN, monitor complete blood counts (CBC) and adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for excessive myelosuppression. Evaluate the bone marrow in patients with prolonged myelosuppression or repeated episodes of myelosuppression to assess leukemia status and marrow cellularity.
Evaluate thiopurine S-methyltransferase (TPMT) and nucleotide diphosphatase (NUDT15) status in patients in patients with severe myelosuppression or repeated episodes of myelosuppression [see Dosage Modifications In Patients With TPMT And NUDT15 Deficiency].
If a patient misses a dose, instruct the patient to continue with the next scheduled dose.
Consider testing for TPMT and NUDT15 deficiency in patients who experience severe myelosuppression or repeated episodes of myelosuppression [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Patients with homozygous deficiency of either enzyme typically require 10% or less of the recommended dosage. Reduce the recommended starting dosage of PURIXAN in patients who are known to have homozygous TPMT or NUDT15 deficiency.
Reduce the PURIXAN dosage based on tolerability. Most patients with heterozygous TPMT or NUDT15 deficiency tolerate recommended dosage, but some require dose reduction based on adverse reactions. Patients who are heterozygous for both TPMT and NUDT15 may require more substantial dose reductions.
Use the lowest recommended starting dosage for PURIXAN in patients with renal impairment (CLcr less than 50 mL/min). Adjust the dosage to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Uses In Specific Populations].
Use the lowest recommended starting dosage for PURIXAN in patients with hepatic impairment. Adjust the dosage to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Uses In Specific Populations].
Reduce the dose of PURIXAN to one-third to one-quarter of the current dosage when coadministered with allopurinol [see DRUG INTERACTIONS].
Shake the bottle vigorously for at least 30 seconds to ensure the oral suspension is well mixed. PURIXAN is a pink to brown viscous oral suspension.
Provide a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL).
Train patients or caregivers on proper handling, storage, administration, disposal and clean-up of accidental spillage prior to initiation of PURIXAN and during each visit to the clinic.
Advise patients and caregivers to use PURIXAN within 8 weeks and properly discard remaining PURIXAN after 8 weeks.
Provide instructions regarding which syringe to use and how to administer the specified dose, since PURIXAN is supplied with 1 mL and 5 mL oral dispensing syringes.
Advise patients that the oral dispensing syringe is intended for multiple uses and provide the following instructions:
PURIXAN is a cytotoxic drug. Follow special handling and disposal procedures.1
2000 mg/100 mL (20 mg/mL) pink to brown in color.
PURIXAN (mercaptopurine) oral suspension is supplied as 2000 mg/100 mL (20 mg/mL) pink to brown viscous liquid in amber glass multiple-dose bottles. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided.
Each carton NDC 62484-0020-2 contains 1 bottle of PURIXAN NDC 62484-0020-1.
PURIXAN is a cytotoxic drug. Follow special handling and disposal procedures1.
REFERENCES
1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
Manufactured by: Nova Laboratories, Ltd Leicester LE18 4YL United Kingdom. Revised: April 2020
The following clinically significant adverse reactions are described elsewhere in the labeling:
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.
Based on multicenter cooperative group ALL trials, the most common adverse reaction occurring in > 20% of patients was myelosuppression, including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20 % of patients included anorexia, nausea, vomiting, diarrhea, malaise, and rash. Adverse reactions occurring in < 5 % of patients included urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, infections, and pancreatitis. Oral lesions resemble thrush rather than antifolic ulcerations. Delayed or late toxicities include hepatic fibrosis, hyperbilirubinemia, alopecia, pulmonary fibrosis, oligospermia and secondary malignancies [see WARNINGS AND PRECAUTIONS].
Drug fever has been reported with PURIXAN.
The following adverse reactions have been identified during postapproval use of PURIXAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: photosensitivity, hypoglycemia, and portal hypertension.
Allopurinol can inhibit the first-pass oxidative metabolism of mercaptopurine by xanthine oxidase, which can lead to an increased risk of mercaptopurine adverse reactions [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]. Reduce the dose of PURIXAN when coadministered with allopurinol [see DOSAGE AND ADMINISTRATION].
The coadministration of PURIXAN with warfarin may decrease the anticoagulant effectiveness of warfarin. Monitor the international normalized ratio (INR) in patients receiving warfarin and adjust the warfarin dosage as appropriate.
PURIXAN can cause myelosuppression. Myelosuppression may be increased when PURIXAN is coadministered with other drugs that cause myelosuppression. Enhanced myelosuppression has been noted in some patients receiving trimethoprim-sulfamethoxazole. Monitor the CBC and adjust the dose of PURIXAN for excessive myelosuppression [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Aminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with PURIXAN. When aminosalicylates and PURIXAN are coadministered, use the lowest possible doses for each drug and monitor more frequently for myelosuppression [see WARNINGS AND PRECAUTIONS].
PURIXAN can cause hepatotoxicity. Hepatotoxicity may be increased when PURIXAN is coadministered with other products that cause hepatotoxicity. Monitor liver tests more frequently in patients who are receiving PURIXAN with other hepatotoxic products [see WARNINGS AND PRECAUTIONS].
Included as part of the "PRECAUTIONS" Section
The most consistent, dose-related adverse reaction of PURIXAN is myelosuppression, manifested by anemia, leukopenia, thrombocytopenia, or any combination of these. Monitor CBC and adjust the dosage of PURIXAN for excessive myelosuppression [see DOSAGE AND ADMINISTRATION].
Consider testing for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency in patients with severe myelosuppression or repeated episodes of myelosuppression. TPMT genotyping or phenotyping (red blood cell TPMT activity) and NUDT15 genotyping can identify patients who have reduced activity of these enzymes. Patients with homozygous TPMT or NUDT15 deficiency may require a dose reduction [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].
Myelosuppression can be exacerbated by coadministration with allopurinol, aminosalicylates or other products that cause myelosuppression [see DRUG INTERACTIONS]. Reduce the dosage of PURIXAN when coadministered with allopurinol [see DOSAGE AND ADMINISTRATION].
Mercaptopurine is hepatotoxic. There are reports of deaths attributed to hepatic necrosis associated with the administration of mercaptopurine. Hepatic injury can occur with any dosage but seems to occur with greater frequency when the recommended dosage is exceeded. In some patients, jaundice has cleared following withdrawal of mercaptopurine and reappeared with rechallenge.
Usually, clinically detectable jaundice appears early in the course of treatment (1 to 2 months); however, jaundice has been reported as early as 1 week and as late as 8 years after starting mercaptopurine. The hepatotoxicity has been associated in some cases with anorexia, diarrhea, jaundice and ascites. Hepatic encephalopathy has occurred.
Monitor serum transaminase levels, alkaline phosphatase, and bilirubin levels at weekly intervals when first beginning therapy and at monthly intervals thereafter. Monitor liver tests more frequently in patients who are receiving PURIXAN with other hepatotoxic drugs [see DRUG INTERACTIONS] or with known pre-existing liver disease. Withhold PURIXAN at onset of hepatotoxicity.
Mercaptopurine is immunosuppressive and may impair the immune response to infectious agents or vaccines. Due to the immunosuppression associated with maintenance chemotherapy for ALL, response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised patients.
Hepatosplenic T-cell lymphoma has been reported in patients treated with mercaptopurine for inflammatory bowel disease (IBD), an unapproved use. Mercaptopurine is mutagenic in animals and humans, carcinogenic in animals, and may increase the risk of secondary malignancies.
Patients receiving immunosuppressive therapy, including mercaptopurine, are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ. The increased risk appears to be related to the degree and duration of immunosuppression. It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder.
A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities. A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders.
Macrophage activation syndrome (MAS) (hemophagocytic lymphohistiocytosis) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine (an unapproved use). If MAS occurs, or is suspected, discontinue PURIXAN. Monitor for and promptly treat infections such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.
PURIXAN can cause fetal harm when administered to a pregnant woman. An increased incidence of miscarriage has been reported in women who received mercaptopurine in the first trimester of pregnancy. Adverse embryo-fetal findings, including miscarriage and stillbirth, have been reported in women who received mercaptopurine after the first trimester of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with PURIXAN and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PURIXAN and for 3 months after the last dose [see Use In Specific Populations].
Advise the patients and caregivers to read the FDA-approved patient labelling (PATIENT INFORMATION and Instructions for Use).
Advise patients and caregivers that PURIXAN can cause myelosuppression, hepatotoxicity, and gastrointestinal toxicity. Advise patients to contact their healthcare provider if they experience fever, sore throat, jaundice, nausea, vomiting, signs of local infection, bleeding from any site, or symptoms suggestive of anemia [see WARNINGS AND PRECAUTIONS].
Advise patients or caregivers on proper handling, storage, preparation, administration, and disposal and clean-up of accidental spillage of the medication prior to initiation and on each visit to the clinic [see DOSAGE AND ADMINISTRATION].
Advise women not to breastfeed during treatment with PURIXAN and for 1 week after the last dose [see Use In Specific Populations].
Advise males and females of reproductive potential that PURIXAN can impair fertility [see Use In Specific Populations].
Instruct patients to minimize sun exposure due to risk of photosensitivity [see ADVERSE REACTIONS].
Mercaptopurine is carcinogenic in animals.
Mercaptopurine causes chromosomal aberrations in cells derived from animals and humans and induces dominant-lethal mutations in the germ cells of male mice.
Mercaptopurine can impair fertility. In mice, surviving female offspring of mothers who received chronic low doses of mercaptopurine during pregnancy were found sterile, or if they became pregnant, had smaller litters and more dead fetuses as compared to control animals.
PURIXAN can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. Pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see Data). Advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Human Data
Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. In a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses.
Animal Data
Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose.
There are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with PURIXAN and for 1 week after the last dose.
PURIXAN can cause fetal harm when administered to pregnant women [see Pregnancy].
Verify the pregnancy status in females of reproductive potential prior to initiating PURIXAN [see Pregnancy].
Females
Advise females of reproductive potential to use effective contraception during treatment with PURIXAN and for 6 months after the last dose.
Males
Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with PURIXAN and for 3 months after the last dose [see Nonclinical Toxicology].
Females and Males
Based on findings from animal studies, PURIXAN can impair female and male fertility [see Nonclinical Toxicology]. The long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied.
Safety and effectiveness of PURIXAN has been established in pediatric patients. Use of PURIXAN in pediatrics is supported by evidence from the published literature and clinical experience. Symptomatic hypoglycemia has been reported in pediatric patients with ALL receiving mercaptopurine. Reported cases were in pediatrics less than 6 years or with a low body mass index.
Clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy.
Use the lowest recommended starting dosage for PURIXAN or increase the dosing interval to every 36 to 48 hours in patients with renal impairment (CLcr less than 50 mL/min). Adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see DOSAGE AND ADMINISTRATION].
Use the lowest recommended starting dosage for PURIXAN in patients with hepatic impairment. Adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see DOSAGE AND ADMINISTRATION].
Signs and symptoms of mercaptopurine overdosage may be immediate (anorexia, nausea, vomiting, and diarrhea) or delayed (myelosuppression, liver dysfunction, and gastroenteritis). Dialysis cannot be expected to clear mercaptopurine. Hemodialysis is thought to be of marginal use due to the rapid intracellular incorporation of mercaptopurine into active metabolites with long persistence.
Withhold PURIXAN immediately if severe or life-threatening adverse reactions occur during treatment. If a patient is seen immediately following an accidental overdosage, it may be useful to induce emesis.
None.
Mercaptopurine is a purine analog that undergoes intracellular transport and activation to form metabolites including thioguanine nucleotides (TGNs). Incorporation of TGNs into DNA or RNA results in cell-cycle arrest and cell death. TGNs and other mercaptopurine metabolites are also inhibitors of de novo purine synthesis and purine nucleotide interconversions. Mercaptopurine was cytotoxic to proliferating cancer cells in vitro and had antitumor activity in mouse tumor models. It is not known which of the biochemical effects of mercaptopurine and its metabolites are directly or predominantly responsible for cell death.
Mercaptopurine exposure-response relationships and the time course of pharmacodynamics response are unknown.
Following a single oral dose of PURIXAN 50 mg under fasted conditions to adult healthy subjects, the median (min – max) AUC0-INF was 137 h•ng/mL (77 – 268 h•ng/mL) and Cmax was 93 ng/mL (40 – 204 ng/mL).
PURIXAN is absorbed after oral administration with a median (min – max) Tmax of 0.75 (0.33 – 2.5) hours.
Effect of Food
Food has been shown to decrease the exposure of mercaptopurine.
The volume of distribution exceeds total body water with a mean volume of distribution of approximately 0.9 L/kg. There is negligible entry of mercaptopurine into cerebrospinal fluid.
Plasma protein binding averages 19% over the concentration range 10 to 50 mcg/L.
The median (min – max) elimination half-life (t1/2) was 1.3 (0.9 – 5.4) hours.
Metabolism
Mercaptopurine is inactivated via two major pathways. One is thiol methylation, which is catalyzed by the polymorphic enzyme thiopurine S-methyltransferase (TPMT), to form the inactive metabolite methylmercaptopurine. The second inactivation pathway is oxidation, which is catalyzed by xanthine oxidase. The product of oxidation is the inactive metabolite 6-thiouric acid.
Elimination
After oral administration of mercaptopurine, urine contains intact mercaptopurine, thiouric acid (formed by direct oxidation by xanthine oxidase, probably via 6-mercapto-8-hydroxypurine), and a number of 6-methylated thiopurines. In one subject, a total of 46% of the dose could be accounted for in the urine (as parent drug and metabolites) in the first 24 hours.
Wide inter individual variations in systemic exposure is observed. Following oral administration of 50 mg/m2 mercaptopurine in 10 children, median plasma concentrations 1 hour post dose was 0.35 (range 0.03 to 1.03) μM and median AUC1–5hours was 56 (range 23 to 65) μM·min. Tmax ranged from 1 to 3 hours.
Several published studies indicate that patients with reduced TPMT or NUDT15 activity receiving usual doses of mercaptopurine, accumulate excessive cellular concentrations of active 6-TGNs, and are at higher risk for severe myelosuppression [see WARNINGS AND PRECAUTIONS]. In a study of 1028 children with ALL, the approximate tolerated mercaptopurine dosage for patients with TPMT and/or NUDT15 deficiency on mercaptopurine maintenance therapy (as a percentage of the planned dosage) was as follows: heterozygous for either TPMT or NUDT15, 50-90%; heterozygous for both TPMT and NUDT15, 30-50%; homozygous for either TPMT or NUDT15, 5-10%.
Approximately 0.3% (1:300) of patients of European or African ancestry have two loss-of-function alleles of the TPMT gene and have little or no TMPT activity (homozygous deficient or poor metabolizers), and approximately 10% of patients have one loss-of-function TPMT allele leading to intermediate TPMT activity (heterozygous deficient or intermediate metabolizers). The TPMT*2, TPMT*3A, and TPMT*3C alleles account for about 95% of individuals with reduced levels of TPMT activity.
NUDT15 deficiency is detected in <1% of patients of European or African ancestry. Among patients of East Asian ancestry (i.e., Chinese, Japanese, Vietnamese), 2% have two loss-of-function alleles of the NUDT15 gene, and approximately 21% have one loss-of-function allele. The p.R139C variant of NUDT15 (present on the *2 and *3 alleles) is the most commonly observed, but other less common loss-of-function NUDT15 alleles have been observed.
Consider all clinical information when interpreting results from phenotypic testing used to determine the level of thiopurine nucleotides or TPMT activity in erythrocytes, since some coadministered drugs can influence measurement of TPMT activity in blood, and blood from recent transfusions will misrepresent a patient’s actual TPMT activity [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
PURIXAN®
(pure-ee-zan)
(mercaptopurine) oral suspension
What is PURIXAN?
PURIXAN is a prescription medicine used along with other medicines to treat people with acute lymphoblastic leukemia (ALL).
What should I tell my healthcare provider before taking PURIXAN?
Before you take PURIXAN, tell your healthcare provider about all of your medical conditions, including if you:
If you are a female who is able to become pregnant:
If you are a male with a female partner who is able to become pregnant:
How should I take PURIXAN?
What should I avoid while taking PURIXAN?
PURIXAN can make your skin more sensitive to sunlight. Protect yourself from sunlight during treatment with PURIXAN.
What are the possible side effects of PURIXAN?
PURIXAN can cause serious side effects, including:
Less common side effects of PURIXAN include: loss of appetite, nausea, vomiting, diarrhea, generally do not feel well, and rash.
Low blood sugar (hypoglycemia) can happen, especially in children under six years of age.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PURIXAN.
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 PURIXAN?
How should I dispose of Purixan?
General information about the safe and effective use of PURIXAN.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PURIXAN for a condition for which it was not prescribed. Do not give PURIXAN to other people, even if they have the same symptoms you have. It could harm them. You can ask your healthcare provider or pharmacist for information about PURIXAN that is written for health professionals.
What are the ingredients in PURIXAN?
Active ingredient: mercaptopurine
Inactive ingredients: xanthan gum, aspartame, concentrated raspberry juice, sucrose, ethyl parahydroxybenzoate sodium, methyl parahydroxybenzoate sodium, potassium sorbate, sodium hydroxide and purified water.
Instructions for Use
PURIXAN®
(pure-ee-zan)
(mercaptopurine) oral suspension
20 mg/mL
Read these Instructions for Use before you start taking PURIXAN, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Important information about measuring PURIXAN oral suspension
If you did not receive an oral dispensing syringe with your PURIXAN oral suspension, ask your pharmacist to give you one.
You will also need disposable gloves.
Important Information You Need to Know Before Administering PURIXAN:
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Preparing a dose of PURIXAN:
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Ingredients in PURIXAN
Active ingredient: mercaptopurine
Inactive ingredients: xanthan gum, aspartame, concentrated raspberry juice, sucrose, ethyl parahydroxybenzoate sodium, methyl parahydroxybenzoate sodium, potassium sorbate, sodium hydroxide, and purified water.
Storing PURIXAN
Disposing of PURIXAN
Clean Up Spillage of PURIXAN
Use appropriate personal protective equipment (disposable gloves and eye protection). Mop up and contain spill material in a compatible container. Wash your hands thoroughly afterwards.
PURIXAN Contact with Skin, Eyes, or Clothes
Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. If symptoms appear, seek medical attention.
This “Instructions for Use” has been approved by the U.S. Food and Drug Administration
