Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

PURIXAN (NDA-205919)

(MERCAPTOPURINE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/07/2020 (SUPPL-4)

Approved Drug Label (PDF)

Other

(PLR conversion; please refer to label)

02/20/2018 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Myelosuppression

(Additions and/or revisions are underlined)

Evaluate patients with repeated severe myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. 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 require substantial dosage reductions of PURIXAN.

6 Adverse Reactions

6.1 Clinical Studies Experience

(Additions and/or revisions are underlined)

…Adverse reactions occurring 5 to 20 % include anorexia, nausea, vomiting, diarrhea, malaise, and rash. Adverse reactions occurring in < 5 % of patients include urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, infections, and pancreatitis…

05/08/2017 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Treatment Related Malignancies

(Additions and/or revisions are underlined)

Cases of hepatosplenic T-cell lymphoma have been reported in patients treated with mercaptopurine for inflammatory bowel disease (IBD), an unapproved use…

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.

5.6 Macrophage Activation Syndrome

(Newly added subsection)

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 mercaptopurine. Monitor for and promptly treat infections such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following serious adverse reactions are described elsewhere in the prescribing information:

Macrophage Activation Syndrome

6.2 Postmarketing Experience

(Newly added subsection)

The following adverse reactions have been identified during post-approval 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, portal hypertension and pancreatitis.

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions are underlined)

The evidence for efficacy of mercaptopurine in children with ALL is derived from the published literature and clinical experience. Cases of symptomatic hypoglycemia have been reported in children with ALL receiving mercaptopurine. Reported cases were in children under the age of six or with a low body mass index.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17. PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patients and caregivers to read the FDA-approved patient labelling (Patient Information and Instructions for Use).

Proper Preparation and Administration

Prior to initiation of PURIXAN and on each visit to the clinic, advise patients or caregivers on proper handling, storage, preparation, administration, and disposal and clean-up of accidental spillage of the medication. Advise patients to minimize sun exposure.

Instruct patients and caregivers to keep PURIXAN out of the reach of children.

PATIENT INFORMATION

(Newly added subsection)

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:

have kidney or liver problems
have a condition where your body produces too little of the enzyme thiopurine methyltransferase (TPMT)
have recently received or plan to receive a vaccine
are pregnant or plan to become pregnant. PURIXAN can harm your unborn baby. You should not become pregnant during treatment with PURIXAN.
are breastfeeding or plan to breastfeed. It is not known if PURIXAN passes into your breast milk. You and your healthcare provider should decide if you will take PURIXAN or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take PURIXAN?

See the detailed “Instructions for Use” that comes with PURIXAN for information about the right way to measure and take a dose of PURIXAN.
Take PURIXAN exactly as your healthcare provider tells you. Do not stop taking PURIXAN or change your dose without talking to your healthcare provider.
Take PURIXAN by mouth 1 time each day.
If Purixan comes into contact with skin, eyes, or clothes?

Remove contaminated clothing.
Wash skin or eyes immediately with water.
Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. If symptoms appear seek medical attention.

During treatment with PURIXAN, your healthcare provider will do regular blood tests to check your blood cell counts and liver function, and may change your dose if you have side effects.
If you miss a dose of PURIXAN, call your healthcare provider for advice.
If you take too much PURIXAN, call your healthcare provider or go to the nearest emergency room right away.

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:

Decreased blood cell counts are common with PURIXAN, but can also be severe. PURIXAN affects your bone marrow and can cause decreased white blood cells, red blood cells, and platelets. Decreased blood cell counts can make you more likely to develop infections, bleeding, or anemia. If you take certain medicines during treatment with PURIXAN, it could make the effects on your bone marrow worse. Tell your healthcare provider if you develop any of the following symptoms during treatment with PURIXAN:

Fever
sore throat
cuts or wounds that are red, or swollen, or are draining
any bleeding
tiredness or weakness
shortness of breath

Liver problems. Increases in liver function test results are common with PURIXAN, but you can also develop severe liver problems with PURIXAN that can lead to death. Your healthcare provider may tell you to stop taking PURIXAN if you develop liver problems. Tell your healthcare provider right away if you develop any of the following symptoms of a liver problem during treatment with PURIXAN:

decreased appetite
diarrhea
nausea or vomiting
yellowing of your skin or the whites of your eyes
a build-up of fluid in your stomach-area (ascites)

Possible increased risk of other cancers. Talk with your healthcare provider about your risk of other cancers if you take PURIXAN.

Less common side effects of PURIXAN include: anorexia, nausea, vomiting, diarrhea, malaise 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?

Store PURIXAN between 59ºF to 77ºF (15ºC to 25ºC), in a dry place. Do not store above 25°C.
Store the oral dispensing syringe in a clean place, with the medicine.
PURIXAN oral suspension should be used within 8 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 8 weeks.
Do not use after the expiry date which is stated on the carton and the bottle after ‘EXP’.
Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
Keep PURIXAN out of the reach of children, preferably in a locked cupboard. If a child accidentally takes PURIXAN, it could cause death.

How should I dispose of Purixan?

This medicine should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of (throw away) PURUIXAN that is no longer needed.

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.