What happens if I overdose Malerone?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include blurred vision or other vision changes; confusion; one-sided weakness; slurred speech.
Proper storage of Malerone solution:
Store Malerone solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, fire, moisture, and light. Do not store in the bathroom. When it is time to throw Malerone solution away, throw away the applicator and cap as well. Keep Malerone solution out of the reach of children and away from pets.
Overdose of Malerone in details
There is one report of acute overdosage with Malerone enanthate injection: Malerone levels of up to 11,400 ng/dL were implicated in a cerebrovascular accident.
Oral ingestion of Malerone is not expected to result in clinically significant serum Malerone concentrations due to extensive first-pass (hepatic) metabolism.
Treatment of overdosage would consist of discontinuation of Malerone together with appropriate symptomatic and supportive care.
What should I avoid while taking Malerone?
Do not apply AndroGel or Malerone Malerone gel to your penis or your scrotum. Malerone gel should also not be applied to your stomach area.
Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel Malerone gel, or 2 hours after applying Malerone Malerone gel.
Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.
If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a Malerone skin patch, avoid using an ointment form of the steroid.
Malerone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
5.1 Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.
- Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It is appropriate to re-evaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices.
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of Malerone. Check hematocrit prior to initiating Malerone treatment. It is appropriate to re-evaluate the hematocrit 3 to 6 months after starting Malerone treatment, and then monitor annually. Discontinue Malerone therapy if the hematocrit becomes elevated. Malerone therapy may be restarted when the hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.
5.3 Venous Thromboembolism
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using Malerone products such as Malerone. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Malerone and initiate appropriate workup and management.
5.4 Cardiovascular Risk
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of Malerone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE) such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of Malerone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Malerone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Malerone.
5.5 Use in Women and Children
Women and children should not use Malerone. Use in women and children has not been studied with Malerone.
Due to lack of controlled studies in women and potential virilizing effects, Malerone is not indicated for use in women and children.
5.6 Potential for Adverse Effects on Spermatogenesis
At large doses of exogenous androgens, including Malerone, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) that could lead to adverse effects on semen parameters including reduction of sperm count.
5.7 Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular Malerone enanthate has produced multiple hepatic adenomas. Malerone is not known to cause these adverse effects.
Androgens, including Malerone, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.
Gynecomastia may develop and persist in patients being treated with androgens, including Malerone, for hypogonadism.
5.10 Sleep Apnea
The treatment of hypogonadal men with Malerone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity and chronic lung disease.
Changes in serum lipid profile may require dose adjustment or discontinuation of Malerone therapy.
Androgens, including Malerone, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
5.13 Decreased Thyroxine-Binding Globulin
Androgens, including Malerone, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free thyroid hormone concentration remains unchanged and there is no clinical evidence of thyroid dysfunction.
5.14 Magnetic Resonance Imaging (MRI)
Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because Malerone contains aluminum, it is recommended to remove the system before undergoing an MRI.
What should I discuss with my healthcare provider before taking Malerone?
Do not use Malerone buccal system if you have cancer of the breast or prostate. Malerone may worsen some cancers of these types.
Before using Malerone buccal system, tell your doctor if you have
had a previous allergic reaction to Malerone;
sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);
difficulty with urination due to enlargement of the prostate;
heart disease; or
liver disease or kidney disease.
You may not be able to use Malerone buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.
Malerone buccal system is not approved for use by women and must not be used by women. Malerone buccal system is in the FDA pregnancy category X. This means that Malerone is known to cause birth defects in an unborn baby. Do not use Malerone buccal system if you are pregnant or could become pregnant during treatment.
Malerone buccal system is not approved for use by women and must not be used by women. It is not known whether Malerone from the buccal system will pass into breast milk. Do not use Malerone buccal system if you are breast-feeding a baby.
Men over 65 years of age that use Malerone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system Malerone, or you may require a lower dose or special monitoring.
The physician should instruct patients to report any of the following:
- Too frequent or persistent erections of the penis.
- Any nausea, vomiting, changes in skin color, or ankle swelling.
- Breathing disturbances, including those associated with sleep.
Virilization of female partners has been reported with use of a topical Malerone solution. Percutaneous creams leave as much as 90 mg residual Malerone on the skin. The results from one study indicated that, after removal of a Malerone (Malerone (transdermal)) system, the potential for transfer of Malerone to a sexual partner was 6 mc g, 1/45th the daily endogenous Malerone production by the female body. Malerone (Malerone (transdermal)) TTS, unlike Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE, has an occlusive backing that prevents the partner from coming in contact with the active material in the system. If a Malerone (Malerone (transdermal)) TTS system is inadvertently transferred to a female partner, it should be removed immediately and the contacted skin washed. Changes in body hair distribution or significant increase in acne of the female partner should be brought to the attention of a physician.
Information for Patients
An information brochure containing instructions for the use of Malerone (Malerone (transdermal)) TTS is available. A separate instruction booklet is available for Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE. These booklets contain important information and instructions on how to properly use and dispose of the Malerone (Malerone (transdermal)) products. Patients should be encouraged to ask questions of the physician and pharmacist.
Advise patients of the following:
- Malerone (Malerone (transdermal)) TTS should not be applied to the scrotum.
- Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only.
- The Malerone (Malerone (transdermal)) products should be applied once daily to dry, clean skin. If the Malerone (Malerone (transdermal)) product has come off after it has been worn for more than 12 hours and it cannot be reapplied, the patient may wait until the next routine application time to apply a new system.
- Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.
- Liver function, prostatic specific antigen, cholesterol, and high-density lipoprotein should be checked periodically.
- To ensure proper dosing, serum Malerone concentrations may be measured.
Anticoagulants: C-17 substituted derivatives of Malerone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.
Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.
Propranolol: In a published pharmacokinetic study of an injectable Malerone product, administration of Malerone cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of Malerone with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.7
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal Data: Malerone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of Malerone into some strains of female mice increases their susceptibility to hepatoma. Malerone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Human Data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.
Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of Malerone replacement therapy.
In men receiving Malerone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Pregnancy Category X :
Teratogenic Effects: The Malerone (Malerone (transdermal)) products are not indicated for women and must not be used in women.
The Malerone (Malerone (transdermal)) products are not indicated for women and must not be used in women.
Safety and efficacy of the Malerone (Malerone (transdermal)) products in pediatric patients has not been established.
What happens if I miss a dose of Malerone?
Call your doctor for instructions if you miss an appointment for your Malerone injection.
- DailyMed. "TESTOSTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "testosterone". http://www.drugbank.ca/drugs/DB00624 (accessed September 17, 2018).
- MeSH. "Androgens". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology