Histrelin

Before taking histrelin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to histrelin or to any of its ingredients
• have diabetes
• have cancer that has spread to the spine
• have a urinary obstruction
• have heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the condition being treated.

The recommended dose of histrelin is 1 implant for 1 year. The implant will deliver approximately 50 mcg of the active drug per day for 12 months.

• Store histrelin implants in the refrigerator, between 2 and 8°C (36 and 46°F). The implantation kit should be stored at room temperature.
• Keep this and all medicines out of the reach of children.

• Antineoplastic agent; a synthetic nonapeptide analog of GnRH (LHRH, gonadorelin).1

• Causes a transient surge in circulating concentrations of LH, FSH, and gonadal steroids (testosterone and dihydrotestosterone in males) following initial administration.1 However, long-term and continuous administration (generally, 2–4 weeks after initiation of therapy) results in decreased levels of LH and FSH due to reversible down-regulation of GnRH receptors in the pituitary gland and desensitization of the pituitary gonadotropes, resulting in marked reduction in serum testosterone concentrations.1

• Reductions in serum testosterone concentrations following histrelin therapy comparable to those achieved after surgical castration (i.e., <50 ng/dL).1

• Commercially available as nonbiodegradable, diffusion-controlled implant.1

• Not active when given orally.1

(his TREL in)

Central precocious puberty (Supprelin LA): Children ≥2 years: SubQ: 50 mg implant surgically inserted every 12 months. Discontinue at the appropriate time for the onset of puberty.

Vantas: CrCl ≥15 mL/minute: No dosage adjustment necessary.

Supprelin LA: There are no dosage adjustments provided in the manufacturer's labeling.

The implant may be slightly curved and/or partially flattened when removed from refrigerator; may roll implant (in sterile-gloved hands) a few times between fingers and thumb. If resistance is felt when inserting implant into insertion tool cannula, remove and manually manipulate or roll as needed and reinsert into cannula.

Concerns related to adverse effects:

• Cardiovascular effects: Androgen-deprivation therapy (ADT) may increase the risk for cardiovascular disease (Levine 2010). An increased risk of MI, sudden cardiac death, and stroke has been reported with GnRH agonist use in men; monitor for symptoms associated with cardiovascular disease. ADT may prolong the QT/QTc interval; consider the benefits of ADT versus the risk for QT prolongation in patients with a history of QTc prolongation, congenital long QT syndrome, heart failure, frequent electrolyte abnormalities, and in patients with medications known to prolong the QT interval, or with pre-existing cardiac disease. Consider periodic monitoring of electrocardiograms and electrolytes in at-risk patients.

• Hyperglycemia: Hyperglycemia has been reported with androgen deprivation therapy (in prostate cancer) and may manifest as diabetes or worsening of preexisting diabetes. Monitor blood glucose and/or HbA1c.

• Pituitary apoplexy: Rare cases of pituitary apoplexy (frequently secondary to pituitary adenoma) have been observed with GnRH agonist administration (onset from 1 hour to usually <2 weeks); may present as sudden headache, vomiting, visual or mental status changes, and infrequently, cardiovascular collapse; immediate medical attention required.

• Psychiatric events: Psychiatric events have been described with GnRH agonists, including histrelin; symptoms of emotional lability, irritability, impatience, anger, and aggression have been reported in postmarketing accounts. Monitor for development or worsening of psychiatric symptoms.

• Seizures: Seizures have been reported in patients receiving GnRH agonists, including histrelin. Reports have occurred in patients with a history of seizures, epilepsy, cerebrovascular disorders, CNS anomalies, or tumors, and patients on concomitant medications associated with seizures (eg, bupropion, SSRIs). Seizures have also been reported in patients without underlying conditions.

• Spinal cord compression: Has been reported, may contribute to paralysis when used for prostate cancer; closely observe patients with metastatic vertebral lesions for weakness and paresthesias in first few weeks of therapy.

• Tumor flare: Transient increases in serum testosterone (in men with prostate cancer) occur during the first week of use and may result in a worsening of disease signs and symptoms (bone pain, neuropathy, hematuria, ureteral/bladder outlet obstruction, spinal cord compression) during the first week of treatment.

• Urinary tract obstruction: Ureteral obstruction may occur when used for prostate cancer; closely observe patients for urinary tract obstruction or poor urine output in first few weeks of therapy.

• Worsening of symptoms: Transient increases in estradiol serum levels (female) or testosterone levels (female and male) may occur during the first week of use for central precocious puberty (CPP); however, manifestations of puberty should decrease within 4 weeks.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Implant complications: Proper surgical insertion technique is essential to avoid complications. Patients should keep arm dry for 24 hours and avoid heavy lifting/strenuous exertion of insertion arm for 7 days after implantation. In prostate cancer studies, the implant was not recovered in a small number of patients. Serum testosterone rose above castrate level and the implant was not palpable or visualized (via ultrasound); it was believed to have been extruded. Some patients had continued testosterone levels below castration level even though the implant was not palpable. If the implant breaks during removal in children with CPP, the remaining pieces should be removed; confirm the removal of the entire implant (refer to manufacturer's instructions for removal procedure).

Histrelin is contraindicated for use during pregnancy or in women who may become pregnant. Adverse events were observed in animal reproduction studies. May cause fetal harm or spontaneous abortion if administered during pregnancy.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience application site irritation, loss of strength or energy, or constipation. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), burning or numbness feeling, urinary retention, change in amount of urine passed, painful urination, hematuria, bone pain, weakness, difficulty moving, severe dizziness, passing out, tachycardia, arrhythmia, or angina (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Histrelin is used help relieve the symptoms of prostate cancer. It is also used to treat central precocious puberty in children. Central precocious puberty is puberty that comes too early.

This drug comes in an implant that a healthcare provider inserts under your skin or your child’s skin.

Histrelin is available as the brand-name drugs Vantas and Supprelin LA. Vantas treats prostate cancer symptoms. Supprelin LA treats central precocious puberty.

• Testosterone increase See Details

• High blood sugar level See Details

• Heart attack and stroke See Details

What is this drug?

This drug is a prescription drug. It comes in pellet that looks like a small, thin, flexible tube. A healthcare provider inserts it under your skin.

This drug is available as the brand-name drug Vantas. It’s not available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

Vantas is used help relieve the symptoms of prostate cancer when the cancer can’t be treated.

How it works

This drug belongs to a class of drugs called gonadotropin-releasing hormone agonists.

See Details