Generic Name: Ipilimumab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Ipilimumab used for?

Ipilimumab is used to treat melanoma (skin cancer). It works by changing the action of your own immune system, directing it to attack skin cancer cells. Unfortunately, other body parts may also be affected

Ipilimumab is a type of medication called a monoclonal antibody.

How should I take Ipilimumab?

This medication is given by injection into a vein by a health care professional. It should be injected slowly over 90 minutes as directed by your doctor. The dosage is based on your medical condition, weight and response to treatment.

Your doctor may prescribe other medications to help with serious side effects if they occur, or your doctor may delay your dose. If the side effects lessen, then treatment with ipilimumab may continue.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Ipilimumab?

Ipilimumab is best stored in the refrigerator at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) and protected from light. Vials should not be shaken or frozen. There may be different brands of Ipilimumab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ipilimumab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ipilimumab?

Before using ipilimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of organ transplant, immune system disorders (such as Guillain-Barre syndrome, lupus, sarcoidosis, Crohn’s disease, ulcerative colitis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age should use reliable forms of birth control during treatment and for 3 months after the last dose of ipilimumab. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ipilimumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ipilimumab. Ipilimumab is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ipilimumab?

Tiredness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ipilimumab?

A product that may interact with this drug: vemurafenib.

Ipilimumab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ipilimumab?

Ipilimumab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ipilimumab?

Ipilimumab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ipilimumab.

What is the dose of Ipilimumab for an adult?

Usual Adult Dose for Melanoma – Metastatic

3 mg/kg IV over 90 minutes every 3 weeks for a maximum of 4 doses

Comment:

-In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose.

Use: For the treatment of unresectable or metastatic melanoma

Usual Adult Dose for Malignant Melanoma of Skin

10 mg/kg IV over 90 minutes every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years or until disease recurrence or unacceptable toxicity

Comments:

-In the event of toxicity, doses should be omitted, not delayed.

Use: Adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

-Mild hepatic impairment (total bilirubin [TB] greater than 1.0 to 1.5 times the upper limit of normal [ULN], or AST greater than ULN): No adjustment recommended.

-Moderate or severe hepatic impairment (TB greater than 1.5 times the ULN): Data not available.

For the development of immune related hepatotoxicity:

-This drug should be withheld in patients with Grade 2 hepatotoxicity.

-This drug should be permanently discontinued in patients with Grade 3 to 5 hepatotoxicity.

Dose Adjustments

IMMUNE-MEDIATED DERMATITIS:

-Treat symptomatically for mild to moderate dermatitis (e.g., localized rash, pruritus); administer topical or systemic corticosteroids if no improvement within 1 week; withhold therapy for moderate to severe dermatologic toxicity; permanently discontinue therapy for Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by dermal ulceration (full thickness) or necrotic, bullous, or hemorrhagic manifestations and initiate prednisone 1 to 2 mg/kg/day (or equivalent); when dermatitis is controlled, taper corticosteroid over at least 1 month.

ENDOCRINOPATHY:

-Withhold therapy for symptomatic endocrinopathy and consider referral to an endocrinologist; initiate prednisone at 1 to 2 mg/kg/day (or equivalent); begin hormone replacement; resume therapy in patients with complete or partial resolution of reactions to Grade 0 or 1 and who are receiving prednisone 7.5 mg daily or less (or equivalent); permanently discontinue therapy for symptomatic endocrinopathy lasting 6 weeks or longer or if unable to reduce prednisone to 7.5 mg daily or less (or equivalent).

GASTROINTESTINAL TOXICITY:

-Moderate Enterocolitis: Withhold therapy; administer an antidiarrheal; if moderate enterocolitis persists for more than 1 week, initiate prednisone at 0.5 mg/kg/day (or equivalent); resume therapy in patients with complete or partial resolution of toxicity (Grade 0 or 1) and who are receiving less than 7.5 mg/day prednisone (or equivalent).

-Severe Enterocolitis: Permanently discontinue therapy; initiate prednisone at 1 to 2 mg/kg/day (or equivalent); upon improvement to Grade 1 or less, taper corticosteroids slowly over at least 1 month (rapid tapering may cause recurrence or worsen symptoms); consider adding anti-TNF or other immunosuppressive therapy for management of immune-mediated enterocolitis unresponsive to 3 to 5 days of systemic corticosteroids or recurring after symptomatic improvement.

NEUROPATHY:

-Withhold therapy for moderate neuropathy (not interfering with daily activities). -Permanently discontinue therapy for severe neuropathy which interferes with daily activities (e.g., Guillain-Barre-like syndromes); consider initiating prednisone at 1 to 2 mg/kg/day (or equivalent) for severe neuropathies.

OPHTHALMOLOGIC TOXICITY:

-Initiate prednisone at 1 to 2 mg/kg/day (or equivalent) for severe immune-mediated adverse reactions.

-Administer corticosteroid eye drops for uveitis, iritis, or episcleritis.

-Permanently discontinue therapy for Grade 2 through 4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic therapy.

OTHER TOXICITIES:

-Withhold therapy for Grade 2 adverse reactions; resume therapy in patients with complete or partial resolution of toxicity (Grade 0 to 1) and who are receiving less than 7.5 mg daily prednisone (or equivalent).

-Permanently discontinue therapy for Grade 2 reactions lasting 6 weeks or longer OR inability to reduce corticosteroid dose to prednisone 7.5 mg/day (or equivalent) OR Grade 3 or 4 toxicities.

-Permanently discontinue therapy for severe immune-mediated adverse reactions; initiate prednisone at 1 to 2 mg/day (or equivalent).

What is the dose of Ipilimumab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ipilimumab available?

Ipilimumab is available in the following dosage forms and strengths:

  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ipilimumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 14, 2018 | Last Modified: August 14, 2018