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These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• Apomorphine (Apokyn), manufactured for Bertek Pharmaceuticals by Draxis Pharma. The FDA has approved apomorphine (Apokyn) as an injectable drug for treating Parkinson’s patients during episodes of hypomobility. Apomorphine was given priority review because injectable apomorphine is the first therapy approved to treat these episodes acutely. Apomorphine also was designated as an orphan product.
Apomorphine must be taken with an anti-emetic drug because, when taken alone, it causes severe nausea and vomiting. It must not be taken with 5-HT3 antagonists because the combination of these drugs can lead to very low blood pressure and loss of consciousness.
Apomorphine is intended for subcutaneous injection only. Apomorphine’s labeling also includes specific warnings about low blood pressure, fainting, hallucinations, and excessive sleepiness.
The most common adverse events seen in controlled trials were yawning, dyskinesias (abnormal movements), nausea and vomiting, sedation or sleepiness, dizziness, runny nose, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.
• Hyaluronidase for injection (Vitrase) by Ista Pharmaceuticals back on market. The FDA has approved hyaluronidase for injection (Vitrase) as an adjunct to other injected drugs to increase their absorption and dispersion.
Hyaluronidase has been used most commonly in combination with local anesthetics in the setting of ophthalmic surgery. Hyaluronidase increases tissue permeability and promotes the spread or dispersion of other drugs. Hyaluronidase also is approved for use as an adjunct to rehydrating agents, and for use with certain imaging agents. Vitrase is a sheep-source (ovine) form of hyaluronidase.
Hyaluronidase has not been available in the United States for the past three years due to the previous manufacturer’s business decision no longer to market the product. This approval was based on product specific manufacturing information together with published literature on hyaluronidase, and other available public information. The manufacturer also conducted a clinical safety study.
Hyaluronidase should not be used to reduce the swelling of bites, stings, and infected or inflamed areas because of the possibility of spreading a localized infection.
• Insulin glulisine [rDNA origin] injection (Apidra) by Aventis. The FDA has approved insulin glulisine [rDNA origin] injection (Apidra) for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. The drug is a recombinant DNA human insulin analogue that has a more rapid onset and a shorter duration of action than regular human insulin after subcutaneous administration.
Insulin glulisine [rDNA origin] injection has been studied in clinical trials in adult patients with Type 1 and Type 2 diabetes. The drug should be injected within 15 minutes before a meal or within 20 minutes after starting a meal and given by subcutaneous injection, or by continuous subcutaneous pump infusion. It has been used in combination with insulin glargine [rDNA origin] injection (Lantus), a 24-hour basal insulin also made by Aventis.
Adverse events commonly associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.
• New indication for doxercalciferol (Hectorol) capsules by Bone Care International. The FDA has approved a new indication and strength for doxercalciferol (Hectorol) capsules. Doxercalciferol, a pro-hormone vitamin D2 analog, is now approved for the treatment of secondary hyperparathyroidism (SHPT) that develops in the earlier stages (Stages 3 and 4) of chronic kidney disease prior to dialysis. It also is approved for the treatment of SHPT in dialysis patients in the United States.