NSB Gleostine_EN_SDS 1.1 2017-11-14

Important Safety Information

GLEOSTINE ^® (lomustine) capsules, for oral use
GLEOSTINE is an alkylating agent indicated for the treatment of patients with:

Brain tumors, primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy.

WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE

See full prescribing information for complete boxed warning.

Delayed Myelosuppression

Gleostine causes myelosuppression including fatal myelosuppression.
Myelosuppression is delayed, dose-related, and cumulative.
Thrombocytopenia is generally more severe than leukopenia. Monitor blood counts and do not give Gleostine more frequently than every 6 weeks.

Risk of Overdosage

PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to patient that only one dose of Gleostine is taken every 6 weeks.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Myelosuppression: Advise patients that periodic assessment of their blood counts are required. Advise patients to contact their healthcare provider for new onset of bleeding or fever or symptoms of infection.
Overdosage: Advise patients that toxicity including fatal toxicity occurs with GLEOSTINE overdosage. Advise patients to take GLEOSTINE as directed:
- GLEOSTINE is taken as a single oral dose that will not be repeated for at least 6 weeks.
- Use of the recommended dose at less than 6 week intervals leads to toxicities including fatal toxicities.
- Each dose may consist of 2 or more different strengths and colors of capsules.
Pulmonary Fibrosis: Advise patients to contact their healthcare provider for new or worsening cough, chest pain, or shortness of breath.
Hepatotoxicity: Inform patients that GLEOSTINE can cause hepatotoxicity and that liver function monitoring during treatment is necessary.
Nephrotoxicity: Inform patients that GLEOSTINE can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary.
Embryo-Fetal Toxicity:Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.Advise females of reproductive potential to use effective contraception during treatment with GLEOSTINE and for at least 2 weeks after the final dose.
Advise male patients with female partners of reproductive potential to use condoms during treatment with GLEOSTINE and for 3.5 months after the final dose.

Adverse Reactions

Common adverse reactions include delayed myelosuppression, nausea, vomiting, stomatitis, and alopecia.

These are not all the possible side effects of GLEOSTINE. Please see Full Prescribing Information for a full list.

Contraindication:

None

Use in Specific Populations

Lactation: Advise women not to breastfeed during treatment with GLEOSTINE and for 2 weeks after the final dose.
Infertility: Advise females and males of reproductive potential of the potential for reduced fertility from GLEOSTINE

The Important Safety Information does not include all the information needed to use GLEOSTINE safely and effectively. Please see accompanying full Prescribing Information for GLEOSTINE.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or
www.fda.gov/MedWatch

GLEOSTINE^® is a trademark of Azurity Pharmaceuticals, Inc.

PP-GLE-US-0003