Pharmacy & Therapeutics - March 2009 - (Page 159) Pharmaceutical Approval Update 200 mg/day have not been studied. The dose should be tapered and should not be abruptly discontinued after extended use. Milnacipran is taken orally with or without food, although taking this drug with food may improve its tolerability. Patients with renal insufficiency. No dosage adjustment is necessary in patients with mild renal impairment. Milnacipran should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (a creatinine clearance of 5 to 29 mL/minute), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily). Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily). Milnacipran is not recommended for patients with end-stage renal disease. Patients with hepatic insufficiency. No dosage adjustment is necessary for patients with hepatic impairment. As with any drug, caution should be exercised in patients with severe hepatic impairment. Commentary: Fibromyalgia, a chronic condition characterized by widespread pain and decreased physical function, afflicts as many as six million people in the U.S. Milnacipran differs from other existing SNRIs, such as venlafaxine (Effexor, Wyeth), which work mostly by preventing the reuptake of serotonin (5-HT). Although SNRIs do stop the reuptake of norepinephrine (NE), they work to a much less powerful extent on this neurotransmitter. Milnacipran however, works almost equally on both NE and 5-HT, providing relief of both pain and depression. Milnacipran also differs from other traditional antidepressants, in that it is not associated with severe reactions associated with those medications, such as weight gain, cardiac problems, and sexual side effects. Sources: www.fda.gov; www.savella.com a duration longer than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use. Ultraviolet light exposure. Animal data suggest that the vehicle of calcitriol ointment may enhance the ability of ultraviolet radiation to induce skin tumors. Subjects who apply the ointment to exposed skin should avoid excessive exposure of the treated area to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use the product. Unevaluated uses. The safety and effectiveness of calcitriol ointment in patients with known or suspected disorders of calcium metabolism or in patients with erythrodermic exfoliative or pustular psoriasis have not been evaluated. Dosage and Administration: The ointment is applied to affected areas twice daily, in the morning and evening. The maximum weekly dose should not exceed 200 g. Calcitriol ointment is not indicated for oral, ophthalmic, or intravaginal use. Commentar y: Psoriasis is a chronic skin disorder that affects 2% to 3% of the U.S. population. Characterized by thick, red, scaly patches of skin, it is caused by an abnormally high growth rate of skin cells that form thick, dry scales (plaques). Psoriasis is also associated with other conditions such as diabetes, heart disease, and obesity. Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term regimens. The availability of this product, which is a form of vitamin D3 with three alcohol groups, has proved safe and well tolerated throughout 52 weeks of continuous use in treating mild-to-moderate disease. A safe, effective long-term therapy is critical for improving overall outcomes for these patients. The other vitamin D topical agent available for treating psoriasis is calcipotriol ointment or cream (Dovonex). Sources: www.fda.gov; www.vectical.com Calcitriol Ointment (Vectical) for Plaque Psoriasis Manufacturer: Galderma Laboratories, Fort Worth, Texas Indication: Calcitriol ointment at a dose of 3 mcg/g is indicated for the topical treatment of mild-to-moderate plaque psoriasis in patients 18 years of age and older. This product should not be applied to the eyes, lips, or facial skin. Drug Class: The ointment is a vitamin D analogue that is applied to the skin. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25triol. The molecular weight is 416.64 daltons. Uniqueness of Product: This is the only vitamin D3 ointment of its kind available in the U.S. Calcitriol is the naturally occurring, active form of vitamin D3, and it is one of the only vitamin D3 products that has been well tolerated in clinical trials even when used on sensitive skin fold areas. Warnings and Precautions: Effects on calcium metabolism. In controlled clinical trials involving participants undergoing laboratory monitoring, hypercalcemia was observed in 24% of subjects exposed to the active drug and in 16% of subjects exposed to the vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the ULN. If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have returned to normal. The effects of the ointment on calcium metabolism after Degarelix Subcutaneous Injection for Prostate Cancer Manufacturer: Ferring Pharmaceuticals, Inc., Parsippany, N.J. Indication: Degarelix is a gonadotropin-releasing hormone (GnRH) receptor antagonist that is designed to treat advanced prostate cancer. Drug Class: This sterile, lyophilized powder for subcutaneous (SQ) injection contains degarelix (as the acetate) and mannitol. This synthetic linear decapeptide amide contains seven synthetic amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density, as obtained after lyophilization. The chemical name is D-alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-Dalanyl-L-ser yl-4-[[[(4s)-hexahydro-2,6-dioxo-4-pyrimidinyl] carbonyl]amino]-L-phenylalanyl-4-[(aminocarbonyl)amino]-Dphenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. The molecular weight is 1,632.3 daltons. Uniqueness of Drug: Degarelix is the only GnRH receptor antagonist approved by the FDA for treating hormonally sensitive late-stage prostate cancer. The drug binds reversibly to the pituitary GnRH receptors, thereby reducing the release Vol. 34 No. 3 • March 2009 • P&T® 159 http://www.fda.gov http://www.savella.com http://www.fda.gov http://www.vectical.com
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