Acthar Gel, H.P.

Name: Acthar Gel, H.P.

Corticotropin Side Effects

Common Side Effects of Corticotropin

Tell your doctor if any of the following side effects become severe or don't go away:

  • Acne
  • Fluid retention
  • Constipation
  • Diarrhea
  • Nausea
  • Heartburn
  • Vomiting
  • Headache
  • Changes in appetite
  • Difficulty sleeping
  • Sweating
  • Restlessness

Serious Side Effects of Corticotropin

Tell your doctor right away if you experience any of the symptoms listed in the Corticotropin Warnings section above, or any of the following serious side effects:

  • Muscle pain
  • Changes in mood
  • Slow wound healing
  • Pain, redness, or swelling at the injection site
  • Seizures
  • Vision problems or changes
  • Severe vomiting, or vomiting up a material that looks like coffee grounds
  • Bloody or tarry stools
  • Signs of a severe allergic reaction (may include itching, hives, rash, difficulty breathing, tightness in the chest, or swelling of the face, mouth, lips, or tongue)

Corticotropin Interactions

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • Biaxin (clarithromycin)
  • Sporanox (itraconazole)
  • Ritodrine — no longer available in the United States
  • Aspirin
  • Advil or Motrin (ibuprofen)
  • Aleve or Naprosyn (naproxen)
  • Diuretics, such as Lasix (furosemide)
  • Tegretol (carbamazepine)
  • Smallpox vaccine or any other "live" vaccine

What is the most important information I should know about Acthar Gel, H.P. (corticotropin)?

You should not use corticotropin if you have adrenal insufficiency (Addison's disease), scleroderma, a fungal infection, herpes infection of the eyes, osteoporosis, a past or present stomach ulcer, congestive heart failure, uncontrolled high blood pressure, recent surgery, or if you are allergic to pork proteins

What should I avoid while using Acthar Gel, H.P. (corticotropin)?

Do not receive a "live" vaccine while using corticotropin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Acthar Gel, H.P. (corticotropin)?

Other drugs may interact with corticotropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

For Healthcare Professionals

Applies to corticotropin: injectable powder for injection, injectable solution

Cardiovascular

Very Common (10% or more): Hypertension
Common (1% to 10%): Cardiac hypertrophy
Frequency not reported: Fluid retention
Postmarketing reports: Necrotizing angitis (adults only), congestive heart failure[Ref]

Dermatologic

Very common (10% or more): Acne
Common (1% to 10%): Rash
Postmarketing reports: Skin thinning (adults only), facial erythema, increased sweating (adults only)[Ref]

Endocrine

Very common (10% or more): Cushingoid
Common (1% to 10%): Cushingoid
Postmarketing reports: Decreased carbohydrate tolerance (infants only), hirsutism[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea
Common (1% to 10%): Constipation, diarrhea, vomiting
Postmarketing reports: Pancreatitis (adults only), abdominal distention, ulcerative esophagitis[Ref]

Hypersensitivity

Postmarketing reports: Allergic responses presenting as dizziness, nausea, and shock (adult only).[Ref]

Metabolic

Common (1% to 10%): Increased appetite, decreased appetite, weight gain
Frequency not reported: Alteration in glucose tolerance
Postmarketing reports: Hypokalemic alkalosis (infants only)[Ref]

Musculoskeletal

Postmarketing reports: Muscle weakness, vertebral compression fractures (infants only)[Ref]

Nervous system

Very Common (10% to more): Convulsions
Common (1% to 10%): Convulsions
Postmarketing reports: Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), reversible brain shrinkage (secondary to hypertension in infants only)[Ref]

Other

Very Common (10% or more): Infection
Common (1% or 10%): Pyrexia, candidiasis, otitis media[Ref]

Psychiatric

Very common (10% or more): Irritability
Common (1% to 10%): Irritability
Frequency not reported: Behavioral and mood changes[Ref]

Respiratory

Common (1% or 10%): Nasal congestion, pneumonia, upper respiratory infections.[Ref]

Some side effects of H.P. Acthar Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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