Xtendrol

Xtendrol (Xtendrol) is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis.

Xtendrol is a man-made steroid, similar to the naturally occurring steroid testosterone. Xtendrol is an "anabolic" steroid that promotes the growth of muscle tissue.

Xtendrol is used to help you regain weight lost after surgery, severe trauma, or chronic infections. Xtendrol is also used in people who cannot gain or maintain a healthy weight for unknown medical reasons.

Xtendrol is also used to decrease muscle loss caused by using steroid medicines, and to reduce bone pain in people with osteoporosis.

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

Therapy with anabolic steroids is adjunctive to and not a replacement for conventional therapy. The duration of therapy with Xtendrol (Xtendrol) will depend on the response of the patient and the possible appearance of adverse reactions. Therapy should be intermittent.

Adults: The response of individuals to anabolic steroids varies. The daily adult dosage is 2.5 mg to 20 mg given in 2 to 4 divided doses. The desired response may be achieved with as little as 2.5 mg or as much as 20 mg daily. A course of therapy of 2 to 4 weeks is usually adequate. This may be repeated intermittently as indicated.

Children: For children the total daily dosage of Xtendrol (Xtendrol) is ≤ 0.1 mg per kilogram body weight or ≤ 0.045 mg per pound of body weight. This may be repeated intermittently as indicated.

Geriatric Use: Recommended dose for geriatric patients is 5 mg bid.

How supplied

Xtendrol (Xtendrol) 2.5 mg tablets are oval, white, and scored with BTG on one side and "11" on each side of the scoreline on the other side; bottles of 100 (NDC 54396-111-11).

Xtendrol (Xtendrol) 10 mg tablets are capsule shaped, white, with BTG on one side and "10" on the other side; bottles of 60 (NDC 54396-110-60).

Manufactured for: Savient Pharmaceuticals, Inc. Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834. Pfizer Co. New York, NY 10017. Address medical inquires to: Savient Pharmaceuticals, Inc. One Tower Center. Fourteenth Floor East Brunswick, NJ 08816. 866-692-6374. Issued January 2006.

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

1. Known or suspected carcinoma of the prostate or the male breast.
2. Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption).
3. Pregnancy, because of possible masculinization of the fetus. Xtendrol (Xtendrol) has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose.
4. Nephrosis, the nephrotic phase of nephritis.
5. Hypercalcemia.

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

• Xtendrol may be taken with or without food.
• If you miss a dose of Xtendrol, 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 Xtendrol.

Use: Labeled Indications

Weight gain (adjunctive therapy): Adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who, without definite pathophysiologic reasons, fail to gain or to maintain normal weight

Other indications included in manufacturer labeling: Adjunctive therapy to offset protein catabolism with prolonged corticosteroid administration; relief of bone pain associated with osteoporosis (current guidelines do not make recommendations regarding use of Xtendrol for osteoporosis related bone pain)

Off Label Uses

Burns, severe (adjunctive therapy)

Data from a systematic review and meta-analysis support the use of Xtendrol as adjunctive therapy in the treatment of adult and geriatric patients with severe burns. Length of stay, donor-site healing time, time between surgical procedures, and decreased weight loss were improved in the catabolic phase. In the rehabilitative stage, length of stay and lean body mass were improved; lean body mass improvements continued into the long-term phase (after 12 months) of burn recovery.

See also:
What other drugs will affect Xtendrol?

Anticoagulants

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

Warfarin: A multidose study of Xtendrol, given as 5 or 10 mg BID in 15 healthy subjects concurrently treated with warfarin, resulted in a mean increase in S-warfarin half-life from 26 to 48 hours and AUC from 4.55 to 12.08 ng*hr/mL: similar increases in R-warfarin half-life and AUC were also detected. Microscopic hematuria (9/15) and gingival bleeding (1/15) were also observed. A 5.5-fold decrease in the mean warfarin dose from 6.13 mg/day to 1.13 mg/day (approximately 80-85% reduction of warfarin dose), was necessary to maintain a target INR of 1.5. When Xtendrol therapy is initiated in a patient already receiving treatment with warfarin, the INR 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 drugs, careful monitoring of the INR or PT, and adjustment of the warfarin dosage if indicated are recommended when the Xtendrol dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.

Oral hypoglycemic agents

Xtendrol may inhibit the metabolism of oral hypoglycemic agents.

Adrenal steroids or ACTH

In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema.

Drug/Laboratory test interactions

Anabolic steroids may decrease levels of thyroxine-binding globulin, resulting in decreased total T₄ serum levels and increased resin uptake of T₃ and T₄. Free thyroid hormone levels remain unchanged. In addition, a decrease in PBI and radioactive iodine uptake may occur.

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

Patients with moderate to severe COPD or COPD patients who are unresponsive to bronchodilators should be monitored closely for COPD exacerbation and fluid retention.

The following adverse reactions have been associated with use of anabolic steroids:

Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy. Reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT)

In males

Prepubertal: Phallic enlargement and increased frequency or persistence of erections.

Postpuberal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability.

In females

Clitoral enlargement, menstrual irregularities.

CNS: Habituation, excitation, insomnia, depression, and changes in libido.

Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.

Breast: Gynecomastia.

Larynx: Deepening of the voice in females.

Hair:Hirsutism and male pattern baldness in females.

Skin:Acne (especially in females and prepubertal males).

Skeletal: Premature closure of epiphyses in children.

Fluid and electrolytes: Edema, retention of serum electrolytes (sodium chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance, increased creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.

Drug Abuse And Dependence

Xtendrol is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic).

A synthetic hormone with anabolic and androgenic properties. [PubChem]