R-Gene 10 (Arginine)

Pfizer, Inc

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In Vivo Diagnostic Biologicals

Pituitary

R-Gene 10 is indicated 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.

R-Gene®10 should always be administered by intravenous infusion because of itshypertonicity. The healthcare professional administering the dose should verify the accuracy of the dose prior to administration

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 RGene® 10. 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 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.

None known

There have been reports of overdosage of R-Gene® 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE® 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE® 10 IN PEDIATRIC PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS, CEREBRAL EDEMA, OR POSSIBLY DEATH. An overdosage may cause a transient metabolic acidosis with hyperventilation, which could lead to death (see “WARNINGS”). In most cases the acidosis will self-compensate and the base deficit will return to normal following completion of the infusion. If the condition persists, the deficit should be determined and corrected by a calculated dose of an alkalizing agent.