R-Gene 10

R-Gene 10

R-Gene 10 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

R-Gene 10 (arginine hydrochloride) Injection is an amino acid used as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism, and problems of growth and stature. Common side effects include nausea, vomiting, headache, flushing, numbness, and local vein irritation.

The recommended adult dose of R-Gene 10 is 30 g arginine hydrochloride (300 mL) administered by intravenous infusion over 30 minutes. R-Gene 10 may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using R-Gene 10. It is unknown if intravenous administration of R-Gene 10 could result in significant quantities of arginine in breast milk. Systemically administered amino acids are secreted into breast milk in quantities not likely to have negative effects on infants. Consult your doctor before breastfeeding.

Our R-Gene 10 (arginine hydrochloride) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

R-Gene 10 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions associated with 1670 infusions in premarketing studies were as follows:

Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients.

One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered. One patient had an apparent decrease in platelet count from 150,000 to 60,000. One patient with a history of acrocyanosis had an exacerbation of this condition following infusion of R-Gene® 10 (arginine hydrochloride injection) .

Post Marketing Experience

The following adverse events have been reported during post-marketing use: extravasation leading to burn-like reaction and/or skin necrosis requiring surgical intervention, hypersensitivity reactions including anaphylaxis, and hematuria that in some cases occurred 1-2 days after an R-Gene 10 (arginine hydrochloride injection) administration. Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for R-Gene 10 (Arginine Hydrochloride Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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