Humira

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Generic Name: Humira Brand Name(s): Generics only. No brands available.

Uses

What is Humira® (adalimumab) used for?

Humira® reduces the effects of a substance in the body that can cause inflammation.

Humira® is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a chronic skin condition called hidradenitis suppurativa. It is also used to treat Crohn’s disease or ulcerative colitis after other drugs have been tried without successful treatment of symptoms.

Humira® may also be used for purposes not listed in this medication guide.

How should I take Humira® (adalimumab)?

Use Humira® exactly as prescribed by your doctor. Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use Humira® regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

The dose schedule for Humira® is highly variable and depends on the condition you are treating. You may need an injection only every other week. Or you may need up to 4 injections in 1 day for 2 days in a row. Follow your doctor’s dosing instructions very carefully.

Humira® is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. Do not inject Humira® into skin that is bruised, red, tender, or hard.

Each prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Do not use a prefilled syringe if the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

How do I store Humira® (adalimumab)?

Humira® is best stored in the refrigerator. To prevent drug damage, do not freeze. There may be different brands of Humira® 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 Humira® 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 Humira® (adalimumab)?

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of Humira® or other medications.
  • You have any other illnesses, disorders, or medical conditions.

You should not use Humira® if you have an active infection.

Some people using Humira® have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Humira®or similar medicines to treat Crohn’s disease or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma.

Before you start treatment with Humira®, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Humira® is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether adalimumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Humira® should not be given to a child younger than 2 years old (or 6 years old if treating Crohn’s disease). Children using Humira® should be current on all childhood immunizations before starting treatment.

Using this medicine may increase your risk of certain types of cancer, such as lymphoma (cancer of the lymph nodes), or melanoma (a tumor that usually affects the skin). You may also develop an autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.

Do not start using Humira® if you have any signs of an infection (fever, chills, night sweats, weight loss, body aches, tiredness, cough with mucus, feeling short of breath, skin sores, stomach pain, diarrhea, pain or burning when you urinate). Call your doctor for instructions.

Adalimumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with Humira®. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.

If you need surgery, tell the surgeon ahead of time that you are using Humira®.

If you have ever had hepatitis B, Humira® can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Humira® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Humira®. Humira® is pregnancy risk category B, 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 Humira® (adalimumab)?

Common side effects may include:

  • Headache
  • Cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat
  • Rash
  • Redness, bruising, itching, or swelling where the injection was given

Also call your doctor at once if you have:

  • Signs of infection – fever, chills, sore throat, vomiting, diarrhea, flu symptoms, pain or burning when you urinate
  • Signs of tuberculosis – fever with ongoing cough, weight loss (fat or muscle)
  • Pale skin, easy bruising or bleeding (nosebleeds, bleeding gums)
  • Numbness, tingly feeling, weakness or prickly feeling
  • Vision problems
  • Shortness of breath with swelling of your ankles or feet
  • New or worsening psoriasis (raised, silvery flaking of the skin)

Stop using Humira® and call your doctor right away if you have any of these symptoms of lymphoma:

  • Fever, night sweats, weight loss, tiredness
  • Feeling full after eating only a small amount
  • Pain in your upper stomach that may spread to your shoulder
  • Easy bruising or bleeding, pale skin, feeling light-headed, rapid heart rate
  • Liver problems – nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)

Older adults may be more likely to develop an infection while using Humira®.

Get emergency medical help if you have any of these signs of an allergic reaction to Humira®: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
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 Humira® (adalimumab)?

Humira® 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.

Products that may interact with this drug are:

  • Abatacept (Orencia)
  • Anakinra (Kineret)
  • Azathioprine (Imuran)
  • Mercaptopurine (Purinethol)
  • Certolizumab (Cimzia)
  • Golimumab (Simponi)
  • Infliximab (Remicade)
  • Rituximab (Rituxan)

Does food or alcohol interact with Humira® (adalimumab)?

Humira® 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 Humira® (adalimumab)?

Humira® 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.

Health conditions that may interact with this drug are:

  • Recent or chronic infections
  • Past or present cancer
  • A history of hepatitis B
  • Congestive heart failure
  • An allergy to latex rubber
  • Any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome
  • if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Humira® (adalimumab).

What is the dose of Humira® (adalimumab) for an adult?

Usual Adult Dose for Ankylosing Spondylitis:

The recommended dose is 40 mg subcutaneously every other week.

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Usual Adult Dose for Rheumatoid Arthritis:

The recommended dose is 40 mg subcutaneously every other week.

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Usual Adult Dose for Psoriatic Arthritis:

The recommended dose is 40 mg subcutaneously every other week.

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Usual Adult Dose for Crohn’s Disease – Acute:

Initial dose: The recommended dose is 160 mg subcutaneously on Day 1.

The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).

Week 2: The recommended dose is 80 mg subcutaneously on Day 15.

Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.

The use of adalimumab for Crohn’s disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Crohn’s Disease – Maintenance:

Initial dose: The recommended dose is 160 mg subcutaneously on Day 1.

The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).

Week 2: The recommended dose is 80 mg subcutaneously on Day 15.

Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.

The use of adalimumab for Crohn’s disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Ulcerative Colitis:

Initial dose: The recommended dose is 160 mg subcutaneously on Day 1.

The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).

Week 2: The recommended dose is 80 mg subcutaneously on Day 15.

Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.

The use of adalimumab for Crohn’s disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Plaque Psoriasis:

Initial dose: The recommended dose is 80 mg subcutaneously.

Maintenance dose: The recommended dose is 40 mg subcutaneously every other week, starting one week after initial dose.

What is the dose of Humira® (adalimumab) for a child?

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

4 to 17 years:

Limited data are available for adalimumab treatment in pediatric patients with a weight below 15 kg.

15 kg (33 lbs) to less than 30 kg (66 lbs): The recommended dose is 20 mg every other week.

Greater than or equal to 30 kg (66 lbs): The recommended dose is 40 mg every other week.

Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics may be continued during treatment with adalimumab.

How is Humira® (adalimumab) available?

Humira® is available in the following dosage forms and strengths:

  • Injection: adalimumab 40mg in 0.8ml; isopropyl alcohol 0.70ml in 1ml

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 Humira®, 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.

msBahasa Malaysia

Sources

Review Date: July 19, 2017 | Last Modified: July 19, 2017

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