Histrelin

Histrelin is a prescription medication indicated for the palliative treatment of advanced prostate cancer in adults and for the treatment of central precocious puberty in pediatric patients.

• Histrelin is available under the following different brand names: Supprelin LA, Vantas

Common side effects of Histrelin include:

• irritation at the implant site (bruising, pain, redness)
• mood swings
• headache
• hot flashes (flushing)
• increased sweating
• night sweats
• tiredness
• swelling of the ankles/feet
• constipation
• shrinking of the testicles
• pain or swelling of the testicles
• reduced sexual interest
• impotence
• difficulty having an orgasm
• nosebleeds
• weight gain or loss
• feeling hot or cold

Serious side effects of Histrelin include:

• none

Rare side effects of Histrelin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Implant

• 50 mg (Vantas)
  • Vantas delivers ~50 mcg/day
• 50mg (Supprelin LA)
  • Supprelin LA delivers ~65mcg/day

Palliative Treatment of Advanced Prostate Cancer

Adult dosage

• Vantas: 1 implant SC every 12 months (50 mg/implant [delivers ~50 mcg/day])

Central Precocious Puberty

Pediatric dosage

• Supprelin LA: 1 implant SC every 12 months (50 mg/implant [delivers 65 mcg/day])

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Histrelin has no noted severe interactions with any other drugs.
• Histrelin has no noted serious interactions with any other drugs.
• Histrelin has no noted moderate interactions with any other drugs.
• Histrelin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions, or concerns.

Contraindications

• Hypersensitivity
• Women who may become or are currently pregnant, children

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Histrelin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Histrelin?”

Cautions

• Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists
• Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists
• Convulsions reported in patients receiving GnRH agonists; 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 also reported in patients in the absence of any of the conditions listed
• Psychiatric events reported in patients taking GnRH agonists; 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
• Reports of MI, sudden cardiac death, and stroke in men treated with GnRH agonists
• Pseudotumor cerebri (idiopathic intracranial hypertension) 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
• QT prolongation
  • Androgen deprivation therapy may prolong the QT/QTc interval; consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval
  • Electrolyte abnormalities should be corrected
  • Consider periodic monitoring of ECG and electrolytes

Pregnancy and Lactation

• Contraindicated during pregnancy since expected hormonal changes that occur with treatment increase the risk for pregnancy loss; the limited data on histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes
• Reproductive potential
  • Based on findings in animals and mechanism of action, therapy may impair fertility in men of reproductive potential
• Lactation
  • There are no data on the presence of the drug in human or animal milk, its effects on breastfed infants or milk production; absorption and systemic activity are not expected from potential exposure to the drug, in breast milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on the breastfed child from the drug or from an underlying maternal condition