Accessing Acthar® Gel (repository corticotropin injection) to treat Infantile Spasms

April 16, 2020

WHAT IS ACTHAR® GEL?

Treatment of infantile spasms in infants and children under 2 years of age.

Acthar is given as an injection into the muscle. Do not inject it under the skin, into a vein, or give it to your child by mouth.

IMPORTANT SAFETY INFORMATION

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

·       A skin condition called scleroderma

·       Bone density loss or osteoporosis

·       Any infections, including fungal, bacterial, or viral

·       Eye infections, such as ocular herpes simplex

·       Had recent surgery

·       Stomach ulcers or a history of stomach ulcers

·       Heart failure

·       Uncontrolled high blood pressure

·       Allergies to pig-derived proteins

·       Have been given or are about to receive a live or live attenuated vaccine

·       Suspected congenital infections (in children under 2 years of age)

·       If you have been told that you have Cushing’s syndrome or Addison’s disease

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking. Include all nonprescription medicines, vitamins, and herbal supplements that you are taking.

What is the most important information I should know about Acthar?

  • Never inject Acthar directly into a vein, under the skin, or give it to your child by mouth
  • Always inject Acthar into the muscle
  • Follow your doctor’s instructions for injecting Acthar
  • Never stop treatment suddenly unless your doctor tells you to do so
  • Try not to miss any scheduled doctor’s appointments. It is important for the doctor to monitor you while taking Acthar

Acthar and corticosteroids have similar side effects.

  • You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores
  • When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing’s syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness
  • Sometimes when you stop taking Acthar long term, your body may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
  • You might develop high blood pressure, or retain too much fluid. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt and taking certain supplements
  • Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use when you are taking Acthar
  • Acthar may hide