Aveed

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• nausea or vomiting;
• changes in skin color;
• increased or ongoing erection of the penis;
• impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;
• painful or difficult urination;
• shortness of breath (even with mild exertion);
• chest pain or pressure, pain spreading to your jaw or shoulder;
• swelling in your ankles or feet, rapid weight gain;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;
• high levels of calcium in the blood--stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or
• liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:

• acne;
• changes in menstrual periods;
• male-pattern hair growth (such as on the chin or chest);
• hoarse or deepened voice; or
• enlarged clitoris.

Common side effects (in men or women) may include:

• breast swelling;
• headache, anxiety;
• increased facial or body hair growth, male-pattern baldness;
• increased or decreased interest in sex;
• numbness or tingly feeling; or
• pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Testosterone is injected into a muscle. A healthcare provider will give you this injection. Testosterone injection is usually given every 2 to 4 weeks.

The length of treatment with testosterone injection will depend on the condition being treated.

Testosterone will not enhance athletic performance and should not be used for that purpose.

While receiving testosterone, you will need frequent blood tests.

Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your testosterone injection.

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.

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.

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.

• It is used to treat low testosterone levels.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Aveed (testosterone undecanoate injection).
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• Wash your hands before and after use.
• It is given as a shot into a muscle.
• Your doctor will give Aveed.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Aveed is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Aveed or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aveed. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Aveed should not be used in any of the following patients:

• Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.3)].
• Women who are or may become pregnant, or who are breastfeeding.  Testosterone can cause fetal harm when administered to a pregnant woman.  Aveed may cause serious adverse reactions in nursing infants.  Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization [see Use in Specific Populations (8.1, 8.3)]. 
• Men with known hypersensitivity to Aveed or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate).

8.1 Pregnancy

Pregnancy Category X:  Aveed is contraindicated in pregnant women or in women who may become pregnant.  Testosterone is teratogenic and may cause fetal harm.  Exposure of a fetus to androgens, such as testosterone, may result in varying degrees of virilizations. If this drug is used in pregnancy or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.

8.3 Nursing Mothers

Although it is not known how much testosterone transfers into human milk, Aveed is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants.  

8.4 Pediatric Use

Safety and effectiveness of Aveed in pediatric patients less than 18 years old have not been established.  Improper use may result in acceleration of bone age and premature closure of epiphyses.

8.5 Geriatric Use

There have not been sufficient numbers of geriatric patients in controlled clinical studies with Aveed to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the153 patients enrolled in the pivotal clinical study utilizing Aveed, 26 (17.0%) were over 65 years of age. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH [see Warnings and Precautions (5.3)].

8.6  Renal Impairment

No studies were conducted in patients with renal impairment.

8.7  Hepatic Impairment

No studies were conducted in patients with hepatic impairment.

9.1  Controlled Substance

Aveed contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

9.2  Abuse

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents.  Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

Abuse-Related Adverse Reactions

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

9.3  Dependence

Behaviors Associated with Addiction

Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:

• Taking greater dosages than prescribed
• Continued drug use despite medical and social problems due to drug use
• Spending significant time to obtain the drug when supplies of the drug are interrupted
• Giving a higher priority to drug use than other obligations
• Having difficulty in discontinuing the drug despite desires and attempts to do so
• Experiencing withdrawal symptoms upon abrupt discontinuation of use

Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

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There have been no reports of overdosage in the Aveed clinical trials. There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. 

Treatment of overdosage would consist of discontinuation of Aveed together with appropriate symptomatic and supportive care.