Drug Safety-related Labeling Changes (SrLC)

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SYNAREL (NDA-019886)

(NAFARELIN ACETATE)

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

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04/22/2022 (SUPPL-38)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

3.         Inform parents and caregivers that reports of convulsions have been observed in patients receiving GnRH agonists. 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 increased risk [see Warnings].

4.         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].

WARNINGS

Additions and/or revisions underlined:

Pseudotumor cerebri (idiopathic intracranial hypertension) has 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

Post-Marketing

Additions and/or revisions underlined:

Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Psychiatric adverse events: Emotional lability, such as crying, irritability, impatience, anger, and aggression has been observed with GnRH agonists [see Warnings]; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists 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.

Central/peripheral nervous adverse events: Convulsion, pseudotumor cerebri (idiopathic intracranial hypertension).

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

MEDICATION GUIDE

Extensive changes; please refer to label

05/19/2017 (SUPPL-33)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions are underlined)

Information for Patients, Patients’ Parents or Guardians

4. Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists. 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 increased risk.

Warnings

(Additions and/or revisions are underlined)

Post-marketing reports of convulsions have been observed in patients receiving GnRH agonists. These 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.

05/19/2017 (SUPPL-35)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions are underlined)

Information for Patients, Patients’ Parents or Guardians

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

WARNINGS

(Additions and/or revisions are underlined)

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

6 Adverse Reactions

ADVERSE REACTIONS

(Additions and/or revisions are underlined)

Post-Marketing

Psychiatric adverse events: Emotional lability, such as crying, irritability, impatience, anger, and aggression has been observed with GnRH agonists; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists 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)

MEDICATION GUIDE SYNAREL (sin-na-rell) (nafarelin acetate) nasal solution

(Medication Guide added; 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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