Drug Safety-related Labeling Changes (SrLC)

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

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04/26/2022 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)

Newly added subsection:

Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists, including leuprolide acetate. 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

Addition of the following to the bulleted line listing:

  • Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [see Warnings and Precautions (5.4)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identifed during postapproval use of leuprolide acetate or FENSOLVI. 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.

Allergic Reactions: anaphylactic, rash, urticaria, and photosensitivity reactions. General: chest pain, weight increase, weight decrease, decreased appetite, fatigue. Laboratory Abnormalities: decreased WBC.

Metabolic: diabetes mellitus.

Musculoskeletal and Connective Tissue: arthralgia, epiphysiolysis, muscle spasms, myalgia.

Neurologic: neuropathy peripheral, convulsion, paralysis, insomnia, pseudotumor cerebri (idiopathic intracranial hypertension).

Psychiatric: 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.

Skin and Subcutaneous Tissue: injection site reactions including induration and abscess, flushing, hyperhidrosis.

Reproductive System: vaginal bleeding, breast enlargement.

Vascular: hypertension, hypotension.

Respiratory: dyspnea.

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


Extensive changes; please refer to label


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, including leuprolide acetate. 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 these symptoms. [see Warnings and Precautions (5.4)].

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information

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