R-Gene 10

INDICATIONS

R-Gene® 10 (arginine hydrochloride injection) 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.

If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene® 10 (arginine hydrochloride injection) is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may not respond to R-Gene® 10 (Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day. Some patients who respond to R-Gene® 10 (arginine hydrochloride injection) do not respond to insulin and vice versa. The rate of false positive responses for R-Gene® 10 (arginine hydrochloride injection) is approximately 32%, and the rate of false negatives is approximately 27%.

DOSAGE AND ADMINISTRATION

Adult Dosage

The recommended adult dose is 30 g arginine hydrochloride (300 mL of R-Gene® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride. See Directions for Use for preparation instructions.

Pediatric Dosage

The recommended pediatric dose is 0.5 g/kg arginine hydrochloride (5 mL/kg of R-Gene® 10 (arginine hydrochloride injection) ) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride.

  • For patients weighing 59 kg or less, withdraw a weight based dose from a sealed R-Gene® 10 (arginine hydrochloride injection) bottle and place in a separate container for intravenous infusion to avoid the inadvertent delivery and administration of the total volume from the commercially available container. See Directions for Use for preparation instructions.
  • For patients weighing 60 kg or more, the recommended dose is 30 g arginine hydrochloride (300 mL of R-Gene® 10 (arginine hydrochloride injection) ). See Directions for Use for preparation instructions

Test Procedure

The intravenous infusion of R-Gene® 10 (arginine hydrochloride injection) is a part of the test for measurement of pituitary reserve of human growth hormone and, for successful administration of the test, clinical conditions and procedures should be as follows:

  1. The test should be scheduled in the morning following a normal night's sleep, and an overnight fast should continue through the test period.
  2. Patients must be placed at bed rest for at least 30 minutes before the infusion begins. Care should be taken to minimize apprehension and distress. This is particularly important in children.
  3. R-Gene® 10 (Arginine Hydrochloride Injection, USP) is a hypertonic solution and should only be infused through an indwelling needle or soft catheter placed in an antecubital vein or other suitable vein (See PRECAUTIONS). Blood samples should be taken by venipuncture from the contra-lateral arm.
  4. A desirable schedule for drawing blood samples is at -30, 0, 30, 60, 90, 120 and 150 minutes.
  5. R-Gene® 10 (arginine hydrochloride injection) should be infused beginning at zero time at a uniform rate which will permit the recommended dose to be administered over 30 minutes.
  6. Blood samples should be promptly centrifuged and the plasma stored at -20°C until assayed by one of the published radioimmunoassay procedures.
  7. Diagnostic test results showing a deficiency of pituitary reserve for HGH should be confirmed by a second test with R-Gene® 10 (arginine hydrochloride injection) , or one may elect to confirm with the insulin hypoglycemia test. A waiting period of one day is advised between tests.

Directions for Use

R-Gene® 10 (arginine hydrochloride injection) is provided as a ready-to-use solution for patients weighing 60 kg (132 lbs) or more and should not be further diluted. For pediatric patients weighing 59 kg (130 lbs) or less a dose must be placed in a separate container. Follow the preparation instructions below.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

For Pediatric Patients weighing 59 kg (130 lbs) or less

Withdraw a weight-based dose from an intact sealed bottle of R-Gene® 10 (arginine hydrochloride injection) . The entire 300 mL bottle of R-Gene® 10 (arginine hydrochloride injection) for infusion is not intended for use in patients weighing 59 kg or less. The dose must be placed in a separate container, such as an evacuated sterile glass container designed for intravenous administration, using aseptic technique.

Additionally, R-Gene® 10 (arginine hydrochloride injection) is stable in polypropylene syringes and plastic containers made of either polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA).

The post-penetration storage period is not more than 4 hours at room temperature or 24 hours at refrigerated temperature (2-8°C).

The healthcare professional administering the dose should berify the accuracy of the dose prior to administration.

Use only if the solution is clear. Discard any unused drug product.

For Adults and Pediatric Patients weighing 60kg (132 lbs) or more

Follow these directions using aseptic technique. As R-Gene® 10 (arginine hydrochloride injection) for intravenous use is provided in glass containers, a standard air-inletting, air-filtering intravenous infusion set with a bacterial air filter is required.

  1. Use only if solution is clear and seal is intact. Carefully examine bottle for evidence of damage, e.g., dents or other evidence of damage to metal cap, small cracks, dents in seal, or areas of dried powder on exterior. Do not administer contents if such damage is found.
  2. Remove tamperproof metal seal and metal disc from bottle to expose rubber stopper, taking care that you do not contaminate the target site of the stopper with fingers, hair, clothing, etc. Immediately perform step #3.
  3. With shut-off clamp closed, remove sterility protector from spike of administration set and immediately insert set with a quick thrust into center of stopper with bottle upright on table. (Push straight in — don't twist — twisting may cause stopper coring.)
  4. Promptly invert bottle to automatically establish fluid level in drip chamber and to check for vacuum by observing rising filtered air bubbles. Discard bottle if there is no vacuum or if the solution is not clear.
  5. Clear tubing of air. Proceed with infusion.

Directions for Use - Illustration

HOW SUPPLIED

R-Gene® 10 (arginine hydrochloride injection) is supplied as a 300 mL fill in 500 mL glass containers. Preservative Free: Discard any unused portion.

NDC 0009-0436-24

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Solution that has been frozen must not be used.

Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Manufactured By: Hospira, Inc. Lake Forest, IL 60045 USA. Revised June 2009

Last reviewed on RxList: 2/11/2010
This monograph has been modified to include the generic and brand name in many instances.

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