AZMIRO- testosterone cypionate injection, solution
Azurity Pharmaceuticals, Inc.
----------
|
MEDICATION GUIDE AZMIRO TM (AZ-MEER-OH) (testosterone cypionate) injection, for intramuscular use, CIII |
| What is the most important information I should know about AZMIRO?
AZMIRO can cause serious side effects, including: • Increase in red blood cell counts (hematocrit) or hemoglobin. o AZMIRO increases red blood cell counts in some people. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks. o You may need to stop AZMIRO if your red blood cell count increases. o Your healthcare provider should check your red blood cell count and hemoglobin while you receive AZMIRO. |
| What is AZMIRO?
AZMIRO is a prescription medicine that contains testosterone. AZMIRO is used to treat adult men who have low or no testosterone due to certain medical conditions. • It is not known if AZMIRO is safe or effective to treat men who have low testosterone due to aging. • It is not known if AZMIRO is safe or effective in children younger than 12 years old. Improper use of testosterone may affect bone growth in children. • AZMIRO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Selling or giving away this medicine may harm others and it is against the law. • AZMIRO is not meant for use in women. |
| Do not receive AZMIRO if you:
• are allergic to AZMIRO or to any ingredients in AZMIRO. See the end of this Medication Guide for a complete list of ingredients in AZMIRO. • have breast cancer. • have or might have prostate cancer. • are a woman who is pregnant. AZMIRO may harm your unborn baby. |
| What should I tell my healthcare provider before receiving AZMIRO?
Before receiving AZMIRO, tell your healthcare provider about all of your medical conditions including if you: • have high red blood cell count (hematocrit) or high hemoglobin laboratory value. • have breast cancer. • have or might have prostate cancer. • have urinary problems due to an enlarged prostate. • have heart problems. • have liver or kidney problems. • have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using AZMIRO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: • insulin. • medicines that decrease blood clotting (blood thinners). • corticosteroids. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine. |
| How will I receive AZMIRO?
• Your healthcare provider will inject AZMIRO deep into the muscle of your buttock. • Your healthcare provider will test your blood before you receive and while you are receiving AZMIRO. |
| What are the possible side effects of AZMIRO? AZMIRO may cause serious side effects including:
See “What is the most important information I should know about AZMIRO?” • Possible increased risk of heart attack or stroke that may or may not lead to death. • If you already have an enlarged prostate, your signs and symptoms may worsen while receiving AZMIRO. This may include: o increased urination at night. o trouble starting your urine stream. o urinating many times during the day. o urge to go to the bathroom right away. o a urine accident. o inability to pass urine or weak urine flow. • Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you receive AZMIRO. • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. • Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with AZMIRO. • AZMIRO may lower your sperm count. • Liver problems. Symptoms of liver problems may include: o nausea or vomiting. o yellowing of your skin or whites of your eyes. o dark urine. o pain on the right side of your stomach area (abdominal pain). • Swelling of your ankles, feet, or body (edema), with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease. • Breathing problems while you sleep (sleep apnea). • Enlarged or painful breasts. • Changes in certain blood tests. These changes include changes in liver tests, increased calcium, decreased thyroid hormones, and increased prolactin hormones (hormone made by pituitary gland) levels. • Increased risk in children of bone growth problems. AZMIRO may affect a child’s final adult height (stature). The child’s bone growth should be checked every 6 months while they are receiving AZMIRO. Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effects of AZMIRO include: • injection site reactions including: bruising, bleeding, redness, hardness. • increased red blood cell count. • enlarged or painful breasts. • headache. • depression. Other side effects include more erections than are normal for you or erections that last a long time. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of AZMIRO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| General information about the safe and effective use of AZMIRO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about AZMIRO that is written for healthcare professionals. |
| What are the ingredients in AZMIRO?
Active ingredient: testosterone Inactive ingredients: benzyl alcohol, benzyl benzoate and cottonseed oil. Manufactured for: Azurity Pharmaceuticals, Inc. Woburn, MA 01801 Manufactured by: LSNE-LEON SLU Calle nicostrato vela (pq. Tecchnologico leon), S/N – M1.1-M1.2, Leon, 24009, Spain (ESP) Patent: https://azurity.com/patents_and_trademarks/ This Medication Guide may have been updated. For current Medication Guide Information, please visit www.azmiro.com AZM-PI-00 Rev. MAY2024 |