Aveed

Aveed is a prescription medication used to treat low or no blood testosterone levels in men who do not produce enough natural testosterone on their own.

Aveed belongs to a group of medications called androgens. These work to treat low blood testosterone levels by mimicking the effects of naturally produced testosterone in the body.

This medication is available in an injectable form to be given directly into a muscle by a healthcare professional, typically every 4 weeks for the first two doses, and then every 10 weeks thereafter.

Common side effects of Aveed include acne, injection site pain, and fatigue.

Aveed can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Aveed affects you.

Aveed is a prescription medication used to treat low or no blood testosterone levels in men who do not produce enough natural testosterone on their own due to several different congenital and/or acquired medical conditions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Endo Pharmaceuticals, Inc.

Serious side effects have been reported with Aveed. See the “Aveed Precautions” section.

Common side effects of Aveed include the following:

• acne
• injection site pain
• fatigue
• irritability
• insomnia
• mood swings
• aggression
• injection site redness
• weight gain

This is not a complete list of Aveed side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

• acetohexamide
• amprenavir
• anisindione
• aprepitant
• armodafinil
• bedaquiline
• betamethasone
• betamethasone
• black cohosh
• boceprevir
• bosentan
• brentuximab
• budesonide
• bupropion
• C1 esterase inhibitor
• calcipotriene 
• calcitriol 
• chlorpropamide
• clofarabine
• cobicistat
• conestat alfa
• conivaptan
• corticorelin
• corticotropin
• cortisone
• cosyntropin
• cyclosporine
• dabrafenib
• dalfopristin
• darunavir
• dasabuvir
• dasatinib
• deferasirox
• delavirdine
• dexamethasone
• dicumarol
• diltiazem
• dronedarone
• efavirenz
• emtricitabine
• epirubicin
• etravirine
• fluconazole
• fludrocortisone
• fluvoxamine
• fosamprenavir
• fosaprepitant
• glimepiride
• glipizide
• glyburide
• grepafloxacin
• hydrocortisone
• idelalisib
• imatinib
• insulin of any kind
• interferon beta-1a
• interferon beta-1b
• isavuconazonium
• itraconazole
• lapatinib
• leflunomide
• levothyroxine
• liothyronine
• liotrix
• lomitapide
• lopinavir
• metformin
• methotrexate
• methylprednisolone
• mibefradil
• mifepristone
• mipomersen
• modafinil
• morphine
• naltrexone
• nateglinide
• nefazodone
• nelfinavir
• netupitant
• nilotinib
• ombitasvir
• oxcarbazepine
• peginterferon beta-1a
• posaconazole
• prednisolone
• prednisone
• repaglinide
• rifapentine
• ritonavir
• rufinamide
• saquinavir
• sirolimus
• tacrolimus
• telaprevir
• telithromycin
• teriflunomide
• thioguanine
• thyroid desiccated
• tolazamide
• tolbutamide
• trabectedin
• triamcinolone
• troglitazone
• voriconazole
• warfarin

This is not a complete list of Aveed drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Aveed including the following:

• Clotting of the oily component of Aveed in the lungs. Serious reactions, involving cough, difficulty breathing, throat tightening, chest pain, dizziness, and fainting have been reported to occur during or immediately after the injection of Aveed.  The majority of these events lasted a few minutes and resolved with treatment; however, some lasted up to several hours and some required emergency care and/or hospitalization. Notify your physician immediately if you experience any of these symptoms.
• Worsening of benign prostatic hyperplasia (BPH). Patients with BPH and treated with Aveed are at an increased risk of worsening of signs and symptoms of BPH. Be sure to inform your physician if you have BPH before starting treatment with Aveed. 
• Increased risk of prostate cancer. Patients treated with Aveed may be at an increased risk for developing prostate cancer. Consult with your physician about your risk for developing prostate cancer before beginning treatment with Aveed.
• Increases in red blood cell mass. Increases in red blood cell mass may require discontinuation of Aveed. Your physician will monitor your blood levels during the course of your treatment with Aveed.
• Blood clots. There have been reports of blood clots in patients using Aveed. Seek medical attention immediately if you experience symptoms of pain, swelling, warmth and/or redness in the lower extremities and/or sudden shortness of breath.
• Liver damage. Prolonged use of Aveed has been associated with serious liver damage including peliosis hepatis, cholestatic hepatitis, and jaundice.  Peliosis hepatis can be a life-threatening or fatal complication. Be sure to inform your physician of any liver problems you have or have had in the past before beginning treatment with Aveed.
• General swelling of the extremities. Aveed may cause your body to retain sodium and water. Swelling may be a serious complication in patients with pre-existing heart, kidney, or liver disease. Inform your physician immediately if you notice swelling of your extremities.
• Swelling of breast tissue. Swelling of breast tissue, also known as gynecomastia, can occur in men using Aveed. Inform your physician if this occurs.
• Sleep apnea. Use of Aveed may worsen sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Inform your physician if you have sleep apnea before beginning treatment with Aveed.
• Elevations in blood cholesterol levels. Aveed may cause changes in your blood cholesterol levels that may require dose adjustment, the addition of cholesterol-lowering medications, or the discontinuation of treatment with Aveed.
• Elevations in blood calcium levels. Aveed may cause changes in your blood calcium levels that may require dose adjustment or the discontinuation of treatment with Aveed. Be sure to inform your physician if you have any active cancers before beginning treatment with Aveed.
• Changes in mood and/or aggression. Report any changes in your mental state to your physician immediately.

Do not take Aveed if you:

• are allergic to Aveed or to any of its ingredients
• are a male with breast or prostate cancer
• are a woman who is or may become pregnant

Aveed can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Aveed affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Aveed, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Aveed or to any of its ingredients
• have or have had prostate cancer or an enlarged prostate (BPH)
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aveed falls into category X. It has been shown that women taking Aveed during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Aveed should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known how much Aveed crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, Aveed should not be used if breastfeeding. A choice should be made whether to stop nursing or stop the use of this medication. 

Use Aveed exactly as prescribed.

Aveed is available in an injectable form to be given directly into a muscle by a healthcare professional, typically every 4 weeks for the first two doses, and then every 10 weeks thereafter.

Due to lack of controlled evaluations in women and potential virilizing effects, Aveed is not indicated for use in women.

Anabolic steroids, such as Aveed, are commonly abused.  Abuse is often associated with adverse physical and psychological effects.

If you miss a dose, receive the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and receive your next dose at the regular time. Do not receive two doses of Aveed at the same time.

Receive 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 following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age
• your gender

The recommended dose of Aveed for the treatment of low or no blood testosterone levels in men who do not produce enough natural testosterone on their own due to several different causative congenital and/or acquired medical conditions is 750 mg injected directly into a muscle (intramuscularly) at week 0, again at week 4, and every 10 weeks thereafter.

If you receive too much Aveed, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Aveed is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Serious pulmonary oil microembolism reactions and/or anaphylaxis

• Serious lung and breathing reactions, involving urge to cough, difficulty breathing, throat tightening, chest pain, dizziness, and fainting; and episodes of severe allergic reactions, including life-threatening reactions, have been reported to occur during or immediately after the administration of Aveed. These reactions can occur after any injection of Aveed during the course of therapy, including after the first dose.
• Following each injection of Aveed, your physician will observe you in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious reactions.
• Because of the risks of serious reactions, Aveed is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Aveed REMS Program.