Synasteron

Synasteron®-50 Tablets is indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond. Synasteron®-50 Tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids.

Synasteron is an anabolic steroid, which is a man-made form of a hormone similar to testosterone.

Synasteron is used to treat certain types of anemia (lack of red blood cells), including anemia caused by chemotherapy.

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

Synasteron may also be used for purposes not listed in this medication guide.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral:

Synasteron: 50 mg [scored]

Dosing: Adult

Erythropoietic effects:

Oral: 1 to 5 mg/kg/day once daily; usual effective dose: 1 to 2 mg/kg/day; give for a minimum trial of 3 to 6 months because response may be delayed

Fanconi anemia (off-label use): Limited data available:

Oral: Initial: 2 mg/kg/day (median dose reported); most patients had a documented dose reduction although exact doses were not provided

Duration of therapy: 4.1 years (median for responders); 1.3 years (median for non-responders) (Paustian 2016). Additional data may be necessary to further define the role of Synasteron in this condition.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Anemia, treatment (erythropoietic effect [eg, Fanconi anemia, bone marrow failure syndromes]):

Children and Adolescents:

Oral: Initial: ~2 mg/kg/day, rounded to nearest 12.5 mg (ie, / of the 50 mg tablet); usual range: 1 to 5 mg/kg/day once daily; some have suggested higher dosing initially (2 to 5 mg/kg/day) and after response, a slow taper (eg, decrease dose by 10% to 20% every 3 to 4 months) to lowest effective dose with minimal side effects; typically, therapeutic response of stabilization or improvement in hemoglobin or platelet counts is observed within 3 to 6 months (Camitta 1979; FARF 2014). Note: The National Kidney Foundation recommends against the use of androgens as an adjuvant to erythropoiesis-stimulating agent treatment in anemic patients with chronic kidney disease (KDIGO 2012; KDOQI 2006). Although an FDA-approved indication, Synasteron use in the treatment of aplastic anemia has been replaced by newer therapies with improved outcomes (eg, hematopoietic stem cell transplantation, immunosuppressive therapy) (BSH [Samarasinghe 2017]; NAPAAC [Rogers 2019]).

See also:
What is the most important information I should know about Synasteron?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not use this medication if you are allergic to Synasteron, or if you have prostate cancer, male breast cancer, female breast cancer with high levels of calcium in the blood, severe liver or kidney disease, or if you are pregnant.

Before using Synasteron, tell your doctor if you have liver or kidney disease, heart disease, congestive heart failure, high cholesterol or triglycerides, coronary artery disease, or an enlarged prostate.

Call your doctor at once if you have a serious side effect such as swelling, rapid weight gain, increased or ongoing erection of the penis, changes in skin color, urination problems, or signs of liver damage (nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes).

Women receiving Synasteron may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor as soon as possible if you notice increased acne, changes in menstrual periods, a deepened voice, male pattern baldness or hair growth, an enlarged clitoris, or changes in your sex drive.

To be sure Synasteron is helping your condition and is not causing harmful effects on your liver, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

It may take up to 6 months of using this medicine before your symptoms improve. Tell your doctor if your symptoms do not improve after 3 months of treatment.

Use Synasteron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Synasteron may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Synasteron, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Synasteron.

Use: Labeled Indications

Anemia: Treatment of anemias caused by deficient red cell production. Note: Androgen therapy (eg, Synasteron) is generally not appropriate for the treatment of anemias except in certain rare situations (eg, Fanconi anemia).

Off Label Uses

Fanconi anemia

Data from a limited number of patients in a retrospective review suggests that Synasteron may be beneficial in the treatment of Fanconi anemia. However, due to significant risks associated with therapy, a careful risk vs. benefit assessment is advised. Additional data may be necessary to further define the role of Synasteron in this condition.

See also:
What other drugs will affect Synasteron?

Warfarin: Clinically significant pharmacokinetic and pharmacodynamic interactions between anabolic steroids and warfarin have been reported in healthy volunteers. When anabolic steroid therapy is initiated in a patient already receiving treatment with warfarin, the INR (international normalized ratio) or prothrombin time (PT) should be monitored closely and the dose of warfarin adjusted as necessary until a stable target INR or PT has been achieved. Furthermore, in patients receiving both Synasteron Tablets and warfarin, careful monitoring of the INR or PT and adjustment of the warfarin dosage, if indicated, are recommended when the Synasteron dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.

Anticoagulants: Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain the desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

Drug/Laboratory Test Interferences

Therapy with androgenic anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased total T. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction. Altered tests usually persist for 2 to 3 weeks after stopping anabolic therapy.

Anabolic steroids may cause an increase in prothrombin time.

Anabolic steroids have been shown to alter fasting blood sugar and glucose tolerance tests.

See also:
What are the possible side effects of Synasteron?

Applies to Synasteron: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking Synasteron (the active ingredient contained in Synasteron) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Long-term use of Synasteron can cause liver tumors or blood-filled cysts in your liver or spleen. Call your doctor at once if you have:

• nausea, upper stomach pain;

• rapid weight gain, especially in your face and midsection;

• loss of appetite, dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

• painful or difficult urination;

• increased interest in sex, painful or ongoing erection of the penis;

• loss of interest in sex, impotence, trouble having an orgasm, decreased amount of semen when you ejaculate;

• easy bruising or bleeding (nosebleeds, bleeding gums), any bleeding that will not stop;

• painful swelling in your breasts;

• changes in skin color; or

• shortness of breath (even with mild exertion), swelling in your hands or feet.

Women receiving Synasteron may develop male features, which could be irreversible if treatment is continued. If you are a woman taking Synasteron, tell your doctor right away if you have:

• hoarse or deepened voice;

• increased facial hair, hair growth on the chest;

• male pattern baldness;

• enlarged clitoris;

• changes in your menstrual periods; or

• increased or decreased interest in sex.

Common side effects in both men and women may include:

• acne;

• male pattern baldness;

• breast swelling or tenderness (in men or women);

• feeling restless or excited;

• sleep problems (insomnia); or

• nausea, vomiting, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Synasteron is a synthetic anabolic steroid marketed under the brand name Anapolon by Hoffmann La Roche Limited. Its primary clinical applications include treatment of osteoporosis and anaemia, as well as stimulating muscle growth in malnourished or underdeveloped patients. Anabolic-androgenic steroids (AAS), such as Synasteron, have been abused by bodybuilders and athletes. The uncontrolled misuse of Synasteron can lead to a large variety of detrimental effects, the most often reported of which are cardiovascular events. In 2009, no producers of Synasteron were identified worldwide (SRI 2009), but it was available from 14 suppliers, including 8 U.S. suppliers (ChemSources 2009).