Baliamine X Uses

How do you administer this medicine?
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What is Baliamine X?

Baliamine X injection is used to assess the function of the pituitary gland. It stimulates the pituitary gland to produce growth hormone for the diagnosis of certain conditions.

Baliamine X is to be given only by or under the direct supervision of your doctor.

Baliamine X indications

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Baliamine X® 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.

If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a

test with Baliamine X® 10 is advisable to confirm the negative response. This can be done

after a waiting period of one day. As patients may not respond to Baliamine X® 10 (10%

Baliamine X 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 Baliamine X® 10 do not

respond to insulin and vice versa. The rate of false positive responses for Baliamine X® 10 is

approximately 32%, and the rate of false negatives is approximately 27%.

Uses of Baliamine X in details

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Use: Labeled Indications

Diagnostic aid: As an intravenous (IV) stimulant to the pituitary for the release of human growth hormone (hGH) in patients in whom the measurement of pituitary reserve for hGH can be of diagnostic usefulness. 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.

Off Label Uses

Hyperammonemia (acute) associated with urea cycle disorders

Data from an uncontrolled open-label study conducted over a 25 year period supports the use of intravenous Baliamine X (in combination with sodium benzoate, sodium phenylacetate and adequate caloric provision) for the treatment of acute hyperammonemia associated with urea-cycle disorders resulting in increased survival.

Based on the National Organization for Rare Disorders, the use of Baliamine X is effective and recommended for the management of patients with this condition.

Oral products available in the US are often marketed as dietary supplements. When using these products, patients should take care to ensure that they are receiving pharmaceutical grade supplements of Baliamine X and verify the formulation (free base vs Baliamine X). The National Urea Cycle Disorders Foundation cautions against using oral dietary supplements of Baliamine X (National Urea Cycles Disorder Foundation).

Baliamine X description

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An essential amino acid that is physiologically active in the L-form. [PubChem]

Baliamine X dosage

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution,

Intravenous, as hydrochloride [preservative free]:

Baliamine X 10: 10% (300 mL) [latex free]

Dosing: Adult

Diagnostic aid (pituitary function): Note: Dosing based on Baliamine X hydrochloride product. IV: 30 g as a single dose

Hyperammonemia, acute (urea cycle disorders) (off-label use): Note: Dosing based on Baliamine X hydrochloride product and on specific enzyme deficiency. Therapy should continue until ammonia levels are in normal range. If a loading dose is used, it should not be repeated. Baliamine X dose may be adjusted downward if patient becomes hypotensive and/or when the exact enzyme deficiency is identified. Administer concomitantly with sodium benzoate and sodium phenylacetate along with dialysis (NORD 2012).

Weight-directed dosing:

Argininosuccinate synthetase (ASS, Citrullinemia) or Argininosuccinate lyase (ASL) deficiency: IV: Loading dose: 600 mg/kg followed by a continuous IV infusion of 600 mg/kg/day (NORD 2012)

Carbamyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC) or N-acetylglutamate synthetase (NAGS) deficiency: IV: Loading dose: 200 mg/kg followed by a continuous IV infusion of 200 mg/kg/day (NORD 2012)

Unconfirmed/pending diagnosis: IV: Loading dose: 600 mg/kg followed by a continuous IV infusion of 600 mg/kg/day (NORD 2012); if ASS and ASL are excluded as diagnostic possibilities, reduce dose to 200 mg/kg/day

BSA-directed dosing:

Argininosuccinate synthetase (ASS, Citrullinemia) or Argininosuccinate lyase (ASL) deficiency: IV: Loading dose: 12 g/m/day in 3 to 4 divided doses

Baliamine X interactions

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Cyclosporine - Baliamine X may counteract the antinaturetic effect of cyclosporin. Ibuprofen - Baliamine X may increase the absorption of ibuprofen if taken concomitantly. Organic nitrates - Baliamine X supplements theoretically may potentiate the effects of organic nitrates if taken concomitantly. Sildenafil citrate - Theoretically, Baliamine X supplements taken concomitantly with sildenafil citrate, may potentiate the effects of the drug.

Baliamine X side effects

See also:
What are the possible side effects of Baliamine X?

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 RGene

® 10.

Baliamine X contraindications

The administration of Baliamine X® 10 is contraindicated in persons having highly allergic

tendencies.

Active ingredient matches for Baliamine X:

Arginine HCl in Taiwan.


Unit description / dosage (Manufacturer)Price, USD
Baliamine X 500 mL

List of Baliamine X substitutes (brand and generic names):

Allamin Isotonic 300 mL
Allamin Isotonic 500 mL
Argide 200 mg x 12 Blister x 5 Tablet
Arginin-Euvipharm 1000 mg x 2 Blister x 10 tube x 5 mL

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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