Drug Safety-related Labeling Changes (SrLC)

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SUPPRELIN LA (NDA-022058)

(HISTRELIN ACETATE)

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

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04/22/2022 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Implant Breakage

Subsection title revised

5.5 Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)

Newly added subsection

Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.

6 Adverse Reactions

Additions and/or revisions underlined:

The following serious adverse reactions are described here and elsewhere in the label:

  • Initial Agonist Action [see Warnings and Precautions (5.1)]

  • Implant Breakage [see Warnings and Precautions (5.2)]

  • Psychiatric Events [see Warnings and Precautions (5.3)]

  • Convulsions [see Warnings and Precautions (5.4)]

  • Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [see Warnings and Precautions (5.5)]

6.3 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post approval use of SUPPRELIN LA. 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.

General Disorders and Administration Site Conditions: implant breakage

Psychiatric Disorders: Emotional lability, such as crying, irritability, impatience, anger, and aggression. Depression, including rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.

Nervous System Disorders: seizures. Pseudotumor cerebri (idiopathic intracranial hypertension) have been observed with GnRH agonists.

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

MEDICATION GUIDE

Extensive changes; please refer to label

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)

Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists. Advise patients and caregivers to monitor for headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Advise patients and caregivers to contact their healthcare provider if the patient develops any of these symptoms. [see Warnings and Precautions (5.5)].

11/08/2019 (SUPPL-16)

Approved Drug Label (PDF)

4 Contraindications

‘Pregnancy’ replaces ‘possibility exists that spontaneous abortion may occur’

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; additions and/or revisions underlined:

Risk Summary

SUPPRELIN LA is contraindicated during pregnancy since expected hormonal changes that occur with SUPPRELIN LA treatment increase the risk for pregnancy loss. The limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes.

Consistent with mechanism of action for SUPPRELIN LA, animal reproduction studies showed an increase in fetal loss at clinically relevant exposures.

 

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and post- implantation loss at doses of 1, 3, 5 or 15 mcg/kg/day, approximating clinical exposure based on body surface area. These dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. Histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 3- to 12-times clinical exposures based on body surface area).

8.2 Lactation

PLLR conversion; additions and/or revisions underlined:

Risk Summary

There are no data on the presence of SUPPRELIN LA in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Absorption and systemic activity are not expected from potential exposure to the peptide, histrelin, in the breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUPPRELIN LA and any potential adverse effects on the breastfed child from SUPPRELIN LA or from the underlying maternal condition.

05/19/2017 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Convulsions

(Newly added subsection)

Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Reports with GnRH agonists have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Convulsions

Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at risk.

05/19/2017 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Psychiatric Events

(Newly added subsection)

Psychiatric events have been reported in patients taking GnRH agonists, including SUPPRELIN LA. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with SUPPRELIN LA.

6 Adverse Reactions

6.3 Post-marketing Experience

(Additions and/or revisions are underlined)

Psychiatric Disorders: Emotional lability, such as crying, irritability, impatience, anger, and aggression, has been observed with GnRH agonists, including SUPPRELIN LA; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including SUPPRELIN LA, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Psychiatric Adverse Events

Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression, have been observed in patients receiving GnRH agonists, including SUPPRELIN LA . Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with SUPPRELIN LA.

Medication Guide SUPPRELIN® LA [Suh-Preh-Lin El-Ay] (histrelin acetate) subcutaneous implant

(Extensive revisions to Medication Guide; please refer to label)

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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