Medical Editor: John P. Cunha, DO, FACOEP
What Is H.P. Acthar Gel?
H.P. Acthar (repository corticotropin) Gel is an adrenocorticotropic hormone used to treat relapsing multiple sclerosis (MS), infantile spasms, and nephrotic syndrome (a collection of symptoms that indicate kidney damage). H.P. Acthar Gel is also used to treat 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).
What Are Side Effects of H.P. Acthar Gel?
Side effects of H.P. Acthar Gel include:
- infections,
- stomach ulcers, and
- changes in mood and behavior such as irritability or depression,
- trouble sleeping,
- 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).
Tell your doctor if you have serious side effects of H.P. Acthar Gel including:
- vision problems,
- 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, or seizures).
Dosage for H.P. Acthar Gel
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.
What Drugs, Substances, or Supplements Interact with H.P. Acthar Gel?
H.P. Acthar Gel may interact with "live" vacccines, aspirin used on a daily basis or at high doses, diuretics (water pills), or insulin or oral diabetes medications. Tell your doctor all medications and supplements you use and all vaccines you recently received.
H.P. Acthar Gel During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant during treatment with H.P. Acthar Gel; it may be harmful to a fetus. It is unknown if H.P. Acthar Gel passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
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.
SLIDESHOW
What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; nausea, feeling light-headed; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fever, chills, sore throat, skin warmth or redness, or other signs of an infection;
- unusual changes in mood or behavior;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- a seizure;
- decreased or increased adrenal gland hormones--changes in weight or appetite, tiredness, muscle weakness, skin discoloration, thinning skin, increased body hair, menstrual changes, loss of appetite, stomach pain;
- high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
- low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
- signs of eye infection--swelling, redness, severe discomfort, crusting or drainage; or
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Be sure your family, caregivers, and close friends also know how to help you watch for these side effects.
Corticotropin can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
- increased blood pressure;
- thinning skin, increased sweating;
- fluid retention (swelling in your hands or feet, puffiness in your face);
- mood changes, irritability;
- increased appetite; or
- weight gain.
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.
QUESTION
What kind of disease is multiple sclerosis? See AnswerSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infections [see WARNINGS AND PRECAUTIONS]
- Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal [see WARNINGS AND PRECAUTIONS]
- Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia [see WARNINGS AND PRECAUTIONS]
- Masking Symptoms of Other Diseases [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Perforation and Bleeding [see WARNINGS AND PRECAUTIONS]
- Behavioral and Mood Disturbances [see WARNINGS AND PRECAUTIONS]
- Ophthalmic Effects [see WARNINGS AND PRECAUTIONS]
- Immunogenicity Potential [see WARNINGS AND PRECAUTIONS]
- Negative Effects on Growth and Physical Development [see WARNINGS AND PRECAUTIONS]
- Decrease in Bone Density [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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. The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.
TABLE: Incidence (%) of Adverse Reactions Occurring in ≥2% of Infants and Children Under 2 Years of Age Treated with Acthar Gel
| Adverse Reactions | Recommended | |
| 75 U/m² twice daily n=122, (%) |
150 U/m² once daily n=37 (%) |
|
| Cardiac disorders | ||
| Cardiac Hypertrophy | 3 | 0 |
| Endocrine disorders | ||
| Cushingoid | 3 | 22 |
| Gastrointestinal disorders | ||
| Diarrhea | 3 | 14 |
| Vomiting | 3 | 5 |
| Constipation | 0 | 5 |
| General disorders and administration site conditions | ||
| Irritability | 7 | 19 |
| Pyrexia | 5 | 8 |
| Infections and infestations | ||
| Infection* | 20 | 46 |
| Investigations | ||
| Weight gain | 1 | 3 |
| Metabolism and nutrition disorders | ||
| Increased appetite | 0 | 5 |
| Decreased appetite | 3 | 3 |
| Nervous system disorders | ||
| Convulsion† | 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 |
| *Specific infections that occurred at ≥ 2% were candidiasis, otitis media, pneumonia and upper respiratory tract infections. †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 have been identified during post approval use of Acthar Gel.
Because adverse reactions 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.
Allergic Reactions
Allergic responses have presented as dizziness, nausea, and anaphylaxis (anaphylactic shock, hypotension, respiratory compromise, urticaria, edema).
Cardiovascular
Necrotizing angitis (adults only), congestive heart failure, atrial fibrillation, and palpitations.
Dermatologic
Skin thinning (adults only), facial erythema, and increased sweating (adults only).
Endocrine
Decreased carbohydrate tolerance (infants only), hirsutism, and menstrual irregularities.
Gastrointestinal
Pancreatitis (adults only), abdominal distention, and ulcerative esophagitis.
General Disorders And Administration Site Conditions
Injection site reaction and asthenic conditions (including fatigue, malaise, asthenia, and lethargy).
Infections And Infestations
Investigations
Blood glucose increased.
Metabolic
Hypokalemic alkalosis (infants only) and fluid retention (including peripheral swelling).
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).
Psychiatric Disorders
Insomnia.
Possible Additional Steroidogenic Effects
Based on steroidogenic effects of 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 Acthar Gel are:
Dermatologic
Impaired wound healing, petechiae and ecchymoses, and suppression of skin test reactions.
Metabolic
Negative nitrogen balance due to protein catabolism and alteration in glucose tolerance.
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
DRUG INTERACTIONS
Formal drug-drug interaction studies have not been performed.
Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.
Read the entire FDA prescribing information for H.P. Acthar Gel (Repository Corticotropin Injection)
© H.P. Acthar Gel Patient Information is supplied by Cerner Multum, Inc. and H.P. Acthar Gel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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