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H.P. Acthar Gel

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H.P. Acthar Gel

H.P. Acthar Gel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

H.P. Acthar (repository corticotropin) is used to treat relapsing multiple sclerosis (MS), infantile spasms, and nephrotic syndrome (a collection of symptoms that indicate kidney damage). It is an adrenocorticotropic hormone. H.P. Acthar Gel is also an FDA-approved option for dermatomyositis (a chronic inflammatory disease of skin and muscle associated with patches of raised reddish or scaly rash) and polymyositis (an autoimmune inflammatory disease of muscle). Side effects of H.P. Acthar Gel include infections, stomach ulcers, and changes in mood and behavior such as irritability, depression, or trouble sleeping.

To treat infantile spasms, the recommended dose is 150 U/m2 divided into twice daily intramuscular injections, tapered over a period of two weeks. To treat acute exacerbations of MS, daily intramuscular or subcutaneous doses of 80-120 units for 2-3 weeks may be administered. To treat other disorders and diseases, dosing is individualized depending on the disease and the medical condition of the patient. H.P. Acthar Gel may intensify loss of electrolytes associated diuretic use. H.P. Acthar Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether H.P. Acthar Gel is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, considering the risk and benefit to the mother. Sudden withdrawal of H.P. Acthar Gel may lead to adrenal insufficiency (adrenal glands fail to produce enough of certain hormones) or recurrent symptoms that make it difficult to stop treatment.

Our H.P. Acthar Gel 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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

H.P. Acthar Gel in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • mood changes;
  • acne, dry skin, thinning skin, bruising or discoloration;
  • slow wound healing;
  • increased sweating;
  • headache, dizziness, spinning sensation;
  • upset stomach; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for H.P. Acthar Gel (Repository Corticotropin Injection) »

What is Prescribing information?

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

H.P. Acthar Gel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Please refer to Adverse Reactions in Infants and Children Under 2 Years of Age (Section 6.1.1) for consideration when treating patients with Infantile Spasms. The adverse reactions presented in Section 6.2 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.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

Adverse Reactions in Infants and Children Under 2 Years of Age

While the types of adverse reactions seen in infants and children under age 2 treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen. Below is a summary of adverse reactions specifically tabulated from source data derived from retrospective chart reviews and clinical trials in children under 2 years of age treated for infantile spasms. The number of patients in controlled trials at the recommended dose was too few to provide meaningful incidence rates or to permit a meaningful comparison to the control groups.

TABLE: Incidence (%) of Treatment Emergent Adverse Events Occurring in ≥ 2% of H.P. Acthar Gel (repository corticotropin injection) Infants and Children under 2 years of Age

System Organ Class Recommended 75 U/m² bid
n=122, (%)
150 U/m² qd
n=37(%)
Cardiac disorders
  Cardiac Hypertrophy 3 0
Endocrine disorders
  Cushingoid 3 22
Gastrointestinal disorders
  Constipation 0 5
  Diarrhea 3 14
  Vomiting 3 5
General disorders and administration site conditions
  Irritability 7 19
  Pyrexia 5 8
Infections and infestations
  Infection1 20 46
Investigations
  Weight gain 1 3
Metabolism and nutrition disorders
  Increased appetite 0 5
  Decreased appetite 3 3
Nervous system disorders
  Convulsion2 12 3
Respiratory, thoracic and mediastinal disorders
  Nasal Congestion 1 5
Skin and subcutaneous tissue disorders
  Acne 0 14
  Rash 0 8
Vascular disorders
  Hypertension 11 19
1 Specific infections that occurred at ≥ 2% were candidiasis, otitis media, pneumonia and upper respiratory tract infections. 2 In the treatment of Infantile Spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome). Additionally the spasms sometimes mask other seizures and once the spasms resolve after treatment, the other seizures may become visible.

These adverse reactions may also be seen in adults and children over 2 years of age when treated for other purposes and with different doses and regimens.

Postmarketing Experience

The following adverse reactions associated with the use of H.P. Acthar Gel have been identified from postmarketing experience with H.P. Acthar Gel. Only adverse events that are not listed above as adverse events reported from retrospective chart reviews and non-sponsor conducted clinical trials and those not discussed elsewhere in labeling, are listed in this section. Because the adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to use with H.P. Acthar Gel. Events are categorized by system organ class. Unless otherwise noted these adverse events have been reported in infants, children and adults.

Allergic Reactions

Allergic responses have presented as dizziness, nausea and shock (adults only).

Cardiovascular

Necrotizing angitis (adults only) and congestive heart failure.

Dermatologic

Skin thinning (adults only), facial erythema and increased sweating (adults only).

Endocrine

Decreased carbohydrate tolerance (infants only) and hirsutism.

Gastrointestinal

Pancreatitis (adults only), abdominal distention and ulcerative esophagitis.

Metabolic

Hypokalemic alkalosis (infants only).

Musculoskeletal

Muscle weakness and vertebral compression fractures (infants only).

Neurological

Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).

Possible Additional Steroidogenic Effects

Based on steroidogenic effects of H.P. Acthar Gel certain adverse events may be expected due to the pharmacological effects of corticosteroids. The adverse events that may occur but have not been reported for H.P. Acthar Gel are:

Dermatologic

Impaired wound healing, abscess, petechiae and ecchymoses, and suppression of skin test reactions.

Endocrine

Menstrual irregularities.

Metabolic

Negative nitrogen balance due to protein catabolism.

Musculoskeletal

Loss of muscle mass and aseptic necrosis of femoral and humeral heads.

Neurological

Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.

Ophthalmic

Exophthalmos.

Read the entire FDA prescribing information for H.P. Acthar Gel (Repository Corticotropin 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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