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ACTHAR- repository corticotropin injection


  1. Acthar Gel Can Cause Serious Side Effects Including:
  2. Acthar Gel May:
  3. While Slowly Stopping Your Childs Injections Of Acthar Gel Or After You Stop Giving The Injections, Call Your Doctor Right Away If Your Child Has Any Of The Following:
  4. Symptoms Of Cushings Syndrome Include:
  5. It May Be More Difficult For Your Doctor To Diagnose Other Conditions Or Diseases In Your Child During Treatment With Acthar Gel. During Treatment And After Treatment Ends, Tell Your Doctor If Your Child Has:
  6. Before Your Child Takes Acthar Gel, Read The Section Above "what Is The Most Important Information I Should Know About Acthar Gel?" And Tell Your Doctor If Your Child Has:
  7. How Should I Give Acthar Gel To My Child?
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. Manufactured For:
  11. Patient Information

Acthar Gel Can Cause Serious Side Effects Including: 

1.
Increased risk of infections.

Acthar Gel is a medicine that can affect your child's immune system. When your child is taking Acthar Gel, it can lower the ability of your child's immune system to fight infections.

Acthar Gel May: 

  • make your child more likely to get new infections
  • worsen an infection that your child already has
  • cause an inactive infection to become active, such as tuberculosis (TB)
Before starting Acthar Gel, tell your doctor if your child has:
  • an infection or signs of an infection, such as:
    • fever
    • cough
    • vomiting
    • diarrhea
    • other signs of flu or illness
  • a family member with an infection or signs of an infection
While taking Acthar Gel, your child should:
  • stay away from people who are sick or who have infections
  • tell your doctor right away if your child has any sign of infection such as:
    • fever (but your child may not have a fever with an infection)
    • cough
    • vomiting
    • diarrhea or
    • other signs of illness or flu and
    • any open cuts or sores on his or her body
2.
Effects on the adrenal gland after stopping Acthar Gel.

When your child stops taking Acthar Gel, his or her body may not produce enough of a hormone called cortisol on its own (adrenal insufficiency). Your child may need to take steroid medicine to protect the body until the adrenal gland recovers and is working well again, especially to protect the body if they have surgery or trauma.Do not stop giving your child injections of Acthar Gel without talking to your doctor first.

Your doctor will tell you when and how to slowly stop giving the injections to avoid serious side effects.

While Slowly Stopping Your Childs Injections Of Acthar Gel Or After You Stop Giving The Injections, Call Your Doctor Right Away If Your Child Has Any Of The Following: 

  • appears weak
  • loses weight or has a decrease in appetite
  • appears tired or lacking energy
  • appears pale
  • has stomach pain
  • appears sick or is with a fever
3.
Effects on the adrenal gland while taking Acthar Gel.

When your child is taking Acthar Gel, his or her adrenal gland may produce too much cortisol. This can cause symptoms of Cushing's syndrome. Cushing's syndrome is more common in children who take Acthar Gel for a long time.

Symptoms Of Cushings Syndrome Include: 

  • increased upper body fat around the neck, but not the arms and legs
  • weight gain
  • rounded or "moon" face
  • thin skin, easy bruising, and stretch marks on thighs, belly and trunk
  • slowed growth rates in children
  • weak bones (osteoporosis)
While receiving treatment with Acthar Gel other side effects can happen that are like side effects that happen due to treatment with steroid medicines. The risk of getting side effects may increase the longer your child is treated with Acthar Gel. Side effects may include:
  • increased blood pressure.Your doctor may check your child's blood pressure during treatment. If your child's blood pressure increases, your doctor may talk with you about possible treatment choices.
  • too much water in the body (water retention), increased amount of body salts, and low potassium in the blood.Acthar Gel may cause your child to have an increased amount of body salts and water that stays in the body, and may lower the amount of potassium in your child's blood. Follow your doctor's instructions about if you need to decrease your child's salt intake or if you need to feed your child foods high in potassium.
4.
Your child should not receive certain vaccines during treatment with Acthar Gel.

Your child may receive killed or inactivated vaccines while receiving Acthar Gel. Before your child receives any vaccines, talk to your doctor about which vaccines are safe for your child. Certain vaccines could cause your child to have serious side effects, or the vaccine may not be effective.

5.
Hiding (masking) symptoms of other conditions or diseases.

It May Be More Difficult For Your Doctor To Diagnose Other Conditions Or Diseases In Your Child During Treatment With Acthar Gel. During Treatment And After Treatment Ends, Tell Your Doctor If Your Child Has: 

  • any signs or symptoms of infection.

    Acthar Gel is a prescription medicine that is used to treat infantile spasms in infants and children under 2 years of age.

Before Your Child Takes Acthar Gel, Read The Section Above "what Is The Most Important Information I Should Know About Acthar Gel?" And Tell Your Doctor If Your Child Has: 

  • an infection
  • Diabetes
  • heart problems
  • kidney problems
  • stomach or intestinal problems
  • thyroid problems
  • liver problems
  • neuromuscular problems
  • convulsions or seizures
  • had exposure to someone with Tuberculosis (TB)
  • a previous allergic reaction such as hives, itching or trouble breathing, to Acthar Gel or pork products
  • had recent surgery
  • had a recent vaccination or is scheduled to receive a vaccination
  • a family member who is receiving vaccinations

Tell your doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. Do not start giving a new medicine to your child without first speaking to your doctor.

How Should I Give Acthar Gel To My Child? 

Acthar Gel 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.

  • Inject Acthar Gel exactly as your doctor tells you. Your doctor will tell you where to give the injection, how much to give, how often and when to give it to your child.
  • Do not use Acthar Gel until your doctor has taught you how to give the injection to your child.
  • To give Acthar Gel:
    • Take the bottle from the refrigerator. Do not open the bottle or pry the cap (rubber stopper) off.
    • Warm the contents by rolling the bottle between your hands for a few minutes.
    • Wash your hands.
    • Prepare the skin where you are going to give the injection by wiping it with a new sterile alcohol wipe. Before giving the injection, look at the site prepared for the injection and make sure that it no longer looks wet. A wet site can cause burning.
    • Wipe the top of the vial rubber stopper with a new sterile alcohol wipe.
    • Use a new sterile needle and syringe to draw up the amount of Acthar Gel the doctor has told you to use.
    • Give the injection the way the doctor has instructed you.
    • Return the bottle to the refrigerator as soon as possible.

Keep all of your child's follow-up appointments with your doctor

  • It is important for you to tell your doctor if your child's spasms continue or change in any way during treatment or after treatment has stopped so that they can monitor your child's progress.

Infantile Spasms sometimes hides (masks) other seizures your child or infant may have. Once treated with Acthar Gel, the Infantile Spasms symptoms may disappear. This may allow the other seizures to become visible for the first time. Tell your child's doctor right away if you

Acthar Gel can cause serious side effects.

    • Store vials of Acthar Gel in the refrigerator between 36 F to 46 F (2 C to 8 C).

    Throw away any vials after the expiration date printed on the label.

    Keep Acthar Gel and all other medicines out of the reach of children

    General information About Acthar Gel

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Acthar Gel for a condition for which it has not been prescribed. Do not give Acthar Gel to other people, even if they have the same symptoms. It may harm them.

    This Medication Guide summarizes the most important information about Acthar Gel. If you would like more information, talk with your child's doctor. You can ask your child's doctor or pharmacist for information about Acthar Gel that is written for healthcare professionals. For more information, go to www.acthar.com or call 1-800-778-7898.

Active Ingredient: 

Corticotropin

Inactive Ingredients: 

gelatin, phenol, cysteine, sodium hydroxide and/or acetic acid to adjust pH, and water for injection

Manufactured For: 

Mallinckrodt ARD LLC.
Bedminster, NJ 07921 USA

PL122
Rev 3/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mallinckrodt, the "M" brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.

2019 Mallinckrodt.

Patient Information 

Caretakers of patients with infantile spasms should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to administering Acthar Gel. Patients should be instructed to take Acthar Gel only as prescribed. They should not stop treatment suddenly unless instructed by their physician to do so.

Patients, their caregivers and families should be advised as to the importance of the need for careful monitoring while on and during titration from Acthar Gel treatment and the importance of not missing scheduled doctor's appointments.

Patients, their caregivers and families should be advised that if the patient develops an infection or fever they should contact their physician. They should be educated that a fever may not necessarily be present during infection. The patient should also try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel[seeWarnings and Precautions (5.1)andAdverse Reactions (6.1.1)].

Patients, their caregivers and families should be advised that if the patient experiences an increase in blood pressure they should contact their physician[seeWarnings and Precautions (5.3)andAdverse Reactions (6.1.1)].

Patients, their caregivers and families should be advised that if the patient or the caregiver notices blood or a change in color of the patient's stool they should contact their physician[seeWarnings and Precautions (5.6)].

Caregivers and families of infants and children treated with Acthar Gel should be informed that the patient may show signs of irritability and sleep disturbances. These effects are reversible once Acthar Gel therapy is stopped[seeWarnings and Precautions (5.7)andAdverse Reactions (6.1.1)].

Patients, their caregivers and families should be advised that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases. These effects are reversible once Acthar Gel therapy is stopped[seeWarnings and Precautions (5.12)andAdverse Reactions (6.1.1)].

Patients, their caregivers and families should be advised that the patient may be monitored for signs of adrenal insufficiency such as weakness, fatigue, lethargy, anorexia, weight loss, hypotension, abdominal pain or hyperpigmentation (adults only) after treatment has stopped. Since the recovery of the adrenal gland varies from days to months, patients may need to be protected from the stress of trauma or surgery by the use of corticosteroids during the period of stress[seeWarnings and Precautions (5.2)].

Patients should be advised not to be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel. Additionally, other immunization procedures in patients or in family members who will be in contact with the patient should be undertaken with caution while the patient is taking Acthar Gel[seeWarnings and Precautions (5.4)].

Patients, their caregivers and families should be advised that prolonged use of Acthar Gel in children may result in Cushing's syndrome and associated adverse reactions, may inhibit skeletal growth, and may cause osteoporosis and decreased bone density. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation[seeWarnings and Precautions (5.2),(5.12), and(5.13)andAdverse Reactions (6.1.1)].

Patients, their caregivers and families should be informed that Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder. The patient will need to be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight, and fecal blood loss[seeWarnings and Precautions (5.5)].

In the treatment of Infantile Spasms, other types of seizures 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 with Acthar Gel, the other seizures may become visible. Parents and caregivers should inform their physician of any new onset of seizures so that appropriate management can then be instituted[seeAdverse Reactions (6.1.1)].

Mallinckrodt, the "M" brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.

2019 Mallinckrodt.

Manufactured for:
Mallinckrodt ARD LLC.
Bedminster, NJ 07921 USA

PL065
3/2019



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