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H.P. Acthar

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Overview

What is H.P. Acthar?

H.P. Acthar Gel is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection. Also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH and water for injection.

ACTH is a 39 amino acid peptide with the following chemical formula:



What does H.P. Acthar look like?



What are the available doses of H.P. Acthar?

5 mL multi-dose vial containing 80 USP Units per mL.

What should I talk to my health care provider before I take H.P. Acthar?

How should I use H.P. Acthar?

H.P. Acthar Gel (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

In the treatment of infantile spasms, H.P. Acthar Gel must be administered intramuscularly. The recommended regimen is a daily dose of 150 U/m (divided into twice daily intramuscular injections of 75 U/m) administered over a 2-week period. Dosing with H.P. Acthar Gel should then be gradually tapered over a 2-week period to avoid adrenal insufficiency. The following is one suggested tapering schedule: 30 U/m in the morning for 3 days; 15 U/m in the morning for 3 days; 10 U/m in the morning for 3 days; and 10 U/m every other morning for 6-days. H.P. Acthar Gel is typically dosed based on body surface area (BSA). For calculation of body surface area, use the following formula


What interacts with H.P. Acthar?

Sorry No Records found


What are the warnings of H.P. Acthar?

Sorry No Records found


What are the precautions of H.P. Acthar?

Sorry No Records found


What are the side effects of H.P. Acthar?

Sorry No records found


What should I look out for while using H.P. Acthar?

H.P. Acthar Gel is contraindicated for intravenous administration.

H.P. Acthar Gel is contraindicated where congenital infections are suspected in infants.

Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P. Acthar Gel.

H.P. Acthar Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origin.


What might happen if I take too much H.P. Acthar?

While chronic exposure to H.P. Acthar Gel at high doses can be associated with a variety of potential serious adverse effects, it is not expected that a single high dose, or even several large doses, has the potential for serious adverse effects compared to a standard dose. There have been no reports of death or acute overdose symptoms from H.P. Acthar Gel in clinical studies or in the published literature.

The intramuscular route of administration makes it unlikely that an inadvertent acute overdose will occur. The typical daily dose of H.P. Acthar Gel to treat an infant that has a BSA of 0.4 m would be 60 U/day. Using the 1-cc syringe supplied with H.P. Acthar Gel, the maximum amount that can be injected is 80 U/injection, which is a well-tolerated single dose.


How should I store and handle H.P. Acthar?

Store between 2-8°C (36°-46°F).H.P. Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection) should be warmed to room temperature before using. Do not over pressurize the vial prior to withdrawing the product.Store H.P. Acthar Gel (repository corticotropin injection) under refrigeration between 2° to 8°C (36° to 46°F). Product is stable for the period indicated on the label when stored under the conditions described.H.P. Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection) should be warmed to room temperature before using. Do not over pressurize the vial prior to withdrawing the product.Store H.P. Acthar Gel (repository corticotropin injection) under refrigeration between 2° to 8°C (36° to 46°F). Product is stable for the period indicated on the label when stored under the conditions described.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
H.P. Acthar Gel is contraindicated for intravenous administration.

H.P. Acthar Gel is contraindicated where congenital infections are suspected in infants.

Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P. Acthar Gel.

H.P. Acthar Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origin.

In controlled trials, terazosin capsules have been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin capsules have also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin capsules have been used concomitantly in at least 50 patients on the following drugs or drug classes:

The adverse effects of H.P. Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with H.P. Acthar Gel, but might be expected to occur []

Please refer to () for consideration when treating patients with Infantile Spasms. The adverse reactions presented in are primarily provided for consideration in use in adults and in children over 2 years of age, but these adverse reactions should also be considered when treating infants and children under 2 years of age.

H.P. Acthar Gel causes the release of endogenous cortisol from the adrenal gland. Therefore all the adverse effects known to occur with elevated cortisol may occur with H.P. Acthar Gel administration as well. Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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