Histrelin Acetate, Implant

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KEY POINTS

• This medicine is placed under the skin of the inside of your upper arm to treat symptoms of prostate cancer in men, or to treat central precocious puberty in children.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: hormone

Generic and brand names: histrelin acetate, implant; Vantas; Supprelin LA

What is this medicine used for?

Vantas is placed under the skin of the inside of your upper arm to treat the symptoms of prostate cancer. It is for use in men only and should not be used by women or children.

Supprelin LA is placed under the skin of the inside of the upper arm to treat central precocious puberty (when a child begins to mature too early in life).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Heart disease
• Osteoporosis
• Trouble urinating
• Tumors in the spine

If you are being treated for prostate cancer, also tell your provider if you have ever had:

• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with electrolytes levels in your blood such as low potassium or magnesium

Females of childbearing age: This medicine should not be given to women because it may harm the baby. If you become pregnant, contact your healthcare provider right away. Do not use this medicine if you are pregnant or breast-feeding.

How do I use it?

Your healthcare provider will numb your arm, make a small cut (incision), and then place the medicine under the skin. The cut will be closed with stitches and covered with a bandage. Keep your arm clean and dry for 24 hours. Do not bathe or swim for 24 hours. Keep the bandage in place as directed by your healthcare provider. Avoid heavy lifting and exercise for 7 days. Your healthcare provider will give you complete instructions.

After it is placed under the skin, the medicine stays in your body for 12 months. After 12 months, the implant must be removed. Your healthcare provider may insert a new implant at this time to continue your treatment.

What should I watch out for?

You may have bruising, redness, or swelling on the skin where implants are given. If these reactions are severe or do not go away within 2 weeks, contact your healthcare provider.

This medicine may work its way out of your arm. If you think the implant is coming out, contact your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

If you are receiving Vantas:

Continued treatment with this medicine may affect bone density. You may need to have lab tests regularly to check how this medicine affects you. Keep all appointments for tests.

You may develop diabetes when you take this medicine. If you already have diabetes, it may get worse. Talk with your healthcare provider about this.

This medicine may increase your risk for a heart attack or stroke. Contact your healthcare provider right away if you have chest pain, dizziness, lightheadedness, fainting, or a fast or irregular heartbeat.

Your symptoms may get worse for a few weeks after you get the implant. You may get also new symptoms. Talk with your healthcare provider about this.

If you are receiving Supprelin LA:

In the first few weeks after getting the implant, this medicine may cause a brief increase in some hormones, and during this time you may notice more signs of puberty such as light vaginal bleeding or an increase in breast size in girls. However, within 4 weeks of treatment, you should see signs that puberty is stopping. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

If you are receiving Vantas:

Serious (Report these to your healthcare provider right away.): New or worse bone pain; blood in the urine; trouble urinating; chest pain; fast or irregular heartbeat; severe dizziness or fainting; swelling in your hands, ankles, or feet; yellowing of your skin or eyes; severe pain, redness, bleeding, or swelling at the implant site that doesn’t go away; severe vomiting; seizures.

Other: Weight gain, tiredness, mild redness or bruising at the implant site, constipation, hot flashes, redness or bruising at the implant site, mood changes, headache, breast swelling or tenderness, change in sexual ability or desire, trouble sleeping, decrease in size of testicles.

If you are receiving Supprelin LA:

Serious (Report these to your healthcare provider right away.): Severe pain, redness, bleeding, or swelling at the implant site that doesn’t go away; severe dizziness or fainting; seizures.

Other: Weight gain; mild itching, redness, or bruising at the implant site; changes in menstrual period; mood changes; headache; breast swelling or tenderness; trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin
• Anagrelide (Agrylin)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Doxepin (Silenor)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), and sotalol (Betapace, Sorine)
• HIV medicines such as lopinavir/ritonavir (Kaletra) and saquinavir (Invirase)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), indacaterol (Arcapta Neohaler), olodaterol (Striverdi Respimat), and salmeterol (Serevent)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet) and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Tetrabenazine (Xenazine)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.