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Important Safety Information: FYCOMPA® | HEXALEN®

FYCOMPA® (perampanel) Indication

FYCOMPA® (perampanel) is a prescription medicine used with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older.

FYCOMPA® (perampanel) Important Safety Information

Prescribing Information

Serious Psychiatric and Behavioral Reactions

In the partial-onset clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of clinical trial patients randomized to receive FYCOMPA® at doses of 8 mg and 12 mg/day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA®-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. The combination of alcohol and FYCOMPA® significantly worsened mood and increased anger. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA®. Patients taking FYCOMPA® should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA® may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA®, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including FYCOMPA®, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA® or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm, and/or any unusual changes in mood or behavior. Should suicidal thoughts or behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Dizziness and Gait Disturbance

FYCOMPA® caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA® at doses of 8 mg and 12 mg/day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA® at doses of 8 mg and 12 mg/day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial.

Somnolence and Fatigue

FYCOMPA® caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizures trials randomized to receive FYCOMPA® at doses of 8 mg and 12 mg/day, respectively, compared to 7% of placebo patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizures trials randomized to receive FYCOMPA® at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA® is known.

Falls

Falls were reported in 5% and 10% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA® at doses of 8 mg and 12 mg/day, respectively, compared to 3% of placebo-treated patients.

Withdrawal of AEDs

A gradual withdrawal is generally recommended with antiepileptic drugs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.

Most Common Adverse Reactions

The most common adverse reactions (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety.

Drug Interactions

FYCOMPA® may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA® were decreased when administered with carbamazepine, phenytoin, or oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John’s wort or rifampin should be avoided. Multiple dosing of FYCOMPA® 12 mg/day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA® is used in combination with other CNS depressants.

Pregnancy Category C and Lactation

FYCOMPA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Physicians are advised to recommend that pregnant patients taking FYCOMPA® enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA® is administered to a nursing woman.

Hepatic and Renal Impairment

Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.

Drug Abuse and Dependence

FYCOMPA® is a Schedule III controlled drug substance and has the potential to be abused or lead to drug dependence.

For more information about FYCOMPA® please see Prescribing Information

FYCOMPA® is available by prescription only.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088.


HEXALEN® (altretamine) Indications

Prescribing Information

HEXALEN® (altretamine) is indicated for use as a single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination.

HEXALEN® (altretamine) Important Safety Information

• HEXALEN® should only be given under the supervision of a physician experienced in the use of antineoplastic agents.
• Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of HEXALEN®, and as clinically indicated (see Adverse Reactions).
• Because of the possibility of HEXALEN®-related neurotoxicity, neurologic examination should be performed regularly during HEXALEN® administration (see Adverse Reactions).

CONTRAINDICATIONS

  • HEXALEN® is contraindicated in patients who have shown hypersensitivity to it. HEXALEN® should not be employed in patients with preexisting severe bone marrow depression or severe neurologic toxicity. HEXALEN® has been administered safely, however, to patients heavily pretreated with cisplatin and/or alkylating agents, including patients with preexisting cisplatin neuropathies. Careful monitoring of neurologic function in these patients is essential.

Pregnancy: Category D

  • HEXALEN® has been shown to be embryotoxic and teratogenic in rats and rabbits when given at doses 2 and 10 times the human dose. HEXALEN® may cause fetal damage when administered to a pregnant woman. If HEXALEN® is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

PRECAUTIONS

  • General

    • Neurologic examination should be performed regularly (see Adverse Reactions).

  • Laboratory Tests

    • Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of HEXALEN®, and as clinically indicated (see Adverse Reactions).

  • Drug Interactions

    • Concurrent administration of HEXALEN® and antidepressants of the MAO inhibitor class may cause severe orthostatic hypotension (see Warnings section). Cimetidine, an inhibitor of microsomal drug metabolism, increased altretamine’s half-life and toxicity in a rat model.

    • Data from a randomized trial of HEXALEN® and cisplatin plus or minus pyridoxine in ovarian cancer indicated that pyridoxine significantly reduced neurotoxicity; however, it adversely affected response duration suggesting that pyridoxine should not be administered with HEXALEN® and/or cisplatin (1).

  • Carcinogenesis, Mutagenesis and Impairment of Fertility

    • The carcinogenic potential of HEXALEN® has not been studied in animals, but drugs with similar mechanisms of action have been shown to be carcinogenic. HEXALEN® was weakly mutagenic when tested in strain TA100 of Salmonella typhimurium. HEXALEN® administered to female rats 14 days prior to breeding through the gestation period had no adverse effect on fertility, but decreased post-natal survival at 120 mg/m2/day and was embryocidal at 240 mg/m2/day. Administration of 120 mg/m2/day HEXALEN® to male rats for 60 days prior to mating resulted in testicular atrophy, reduced fertility and a possible dominant lethal mutagenic effect. Male rats treated with HEXALEN® at 450 mg/m2/day for 10 days had decreased spermatogenesis, atrophy of testes, seminal vesicles and ventral prostate.

Pregnancy

  • Pregnancy: Category D under CONTRAINDICATIONS.

Nursing Mothers

  • It is not known whether altretamine is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to HEXALEN® treatment of the mother, it is recommended that breast feeding be discontinued if the mother is treated with HEXALEN®.

Pediatric Use

  • The safety and effectiveness of HEXALEN® in children have not been established.

ADVERSE REACTIONS

  • Gastrointestinal

    • With continuous high-dose daily HEXALEN®, nausea and vomiting of gradual onset occur frequently. Although in most instances these symptoms are controllable with anti-emetics, at times the severity requires HEXALEN® dose reduction or, rarely, discontinuation of HEXALEN® therapy. In some instances, a tolerance of these symptoms develops after several weeks of therapy. The incidence and severity of nausea and vomiting are reduced with moderate-dose administration of HEXALEN®. In 2 clinical studies of single-agent HEXALEN® utilizing a moderate, intermittent dose and schedule, only 1 patient (1%) discontinued HEXALEN® due to severe nausea and vomiting.

  • Neurotoxicity

    • Peripheral neuropathy and central nervous system symptoms (mood disorders, disorders of consciousness, ataxia, dizziness, vertigo) have been reported. They are more likely to occur in patients receiving continuous high-dose daily HEXALEN® (altretamine) than moderate-dose HEXALEN® administered on an intermittent schedule. Neurologic toxicity has been reported to be reversible when therapy is discontinued. Data from a randomized trial of HEXALEN® and cisplatin plus or minus pyridoxine in ovarian cancer indicated that pyridoxine significantly reduced neurotoxicity; however, it adversely affected response duration suggesting that pyridoxine should not be administered with HEXALEN® and/or cisplatin (1).

  • Hematologic

    • HEXALEN® causes mild to moderate dose-related myelosuppression. Leukopenia below 3000 WBC/mm3 occurred in <15% of patients on a variety of intermittent or continuous dose regimens. Less than 1% had leukopenia below 1000 WBC/mm3. Thrombocytopenia below 50,000 platelets/mm3 was seen in <10% of patients. When given in doses of 8-12 mg/kg/day over a 21 day course, nadirs of leukocyte and platelet counts were reached by 3-4 weeks, and normal counts were regained by 6 weeks. With continuous administration at doses of 6-8 mg/kg/day, nadirs are reached in 6-8 weeks (median).

For more information about HEXALEN® please see Prescribing Information.