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Adalimumab-adbm (Subcutaneous)

ay-da-LIM-ue-mab - adbm

Subcutaneous route(Solution)

Patients treated with adalimumab-adbm are at increased risk of infection, some of which may become serious and lead to hospitalization or death. These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria. The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection. Evaluate for latent TB and treat if necessary prior to initiating therapy. Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment. Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers such as adalimumab-adbm. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab-adbm, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis. Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine .

Medically reviewed on Oct 31, 2018

Commonly used brand name(s)

See also: Stelara

In the U.S.

  • Cyltezo

Pharmacologic Class: Adalimumab

Uses For adalimumab-adbm

Adalimumab-adbm injection is used to treat the symptoms and prevent the progression of moderate to severely active rheumatoid arthritis and active ankylosing spondylitis. It is used in children 4 years of age and older for juvenile idiopathic arthritis. Adalimumab-adbm is also used to treat psoriatic arthritis, which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body. Psoriatic arthritis usually occurs with a skin condition called psoriasis. Adalimumab-adbm may be used alone or in combination with other medicines (eg, methotrexate).

Adalimumab-adbm injection is also used to treat the symptoms of active Crohn's disease in adult patients who have not been helped by other medicines, including infliximab. It is also used to treat moderate to moderate to severe ulcerative colitis in patients who have been treated with other medicines (eg, azathioprine, corticosteroids, or 6-mercaptopurine) that did not work well.

Adalimumab-adbm injection may also be used to treat chronic plaque psoriasis, which is a skin disease with red patches and white scales that do not go away.

Adalimumab-adbm is available only with your doctor's prescription.

Before Using adalimumab-adbm

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For adalimumab-adbm, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to adalimumab-adbm or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of adalimumab-adbm injection for the treatment of juvenile idiopathic arthritis in children 4 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age or weighing less than 10 kilograms (kg) for juvenile idiopathic arthritis. Safety and efficacy have also not been established for other uses in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adalimumab-adbm injection in the elderly. However, adalimumab-adbm may cause serious infections and cancer more often in the elderly, which may require caution in patients receiving adalimumab-adbm.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking adalimumab-adbm, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using adalimumab-adbm with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Adenovirus Vaccine
  • Anakinra
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Infliximab
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rilonacept
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Tofacitinib
  • Typhoid Vaccine
  • Varicella Virus Vaccine, Live
  • Yellow Fever Vaccine
  • Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of adalimumab-adbm. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood problems (eg, aplastic anemia, pancytopenia, thrombocytopenia), history of or
  • Congestive heart failure or
  • Guillain-Barré syndrome, history of or
  • Infections (fungal, bacterial), history of or
  • Leukopenia (low number of white blood cells) or
  • Multiple sclerosis or
  • Optic neuritis (eye problem) or
  • Psoriasis (skin disease)—Use with caution. May make these conditions worse.
  • Cancer, active or history of or
  • Chronic obstructive pulmonary disease (COPD) or
  • Granulomatosis polyangiitis—Use with caution. May increase the chance of getting new cancers.
  • Diabetes or
  • Hepatitis B, history of or
  • Opportunistic infections, history of or
  • Tuberculosis, history of—May increase chance for side effects.
  • Infection, active—Should not be used in patients with this condition.
  • Tuberculosis, active—Should be treated first before receiving adalimumab-adbm.

Proper Use of adalimumab-adbm

Adalimumab-adbm is given as a shot under your skin in the upper thighs or stomach. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using adalimumab-adbm at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use adalimumab-adbm.

Adalimumab-adbm comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you use adalimumab-adbm at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

To use the prefilled syringe:

  • Wash your hands with soap and water before and after using adalimumab-adbm.
  • Allow 15 to 30 minutes for the syringe to warm up to room temperature.
  • Do not remove the needle cover on the prefilled syringe while allowing the medicine to reach to room temperature. Remove it before use.
  • Check the liquid in the syringe. It should be clear and colorless to slightly yellow. Do not use the syringe if it is cloudy, discolored, or has particles in it.
  • Do not inject into skin areas that are red, bruised, tender, hard, or scarred.

Dosing

The dose of adalimumab-adbm will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of adalimumab-adbm. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage forms (prefilled syringe):
    • For Crohn's disease:
      • Adults—At first (Day 1), 160 milligrams (mg) injected under the skin (four 40 mg injections in one day or two 40 mg injections a day for two days). Then 2 weeks later (Day 15), a dose of 80 mg is given. A maintenance dose of 40 mg is given at week 4 (Day 29) and every other week thereafter.
      • Children—Use and dose must be determined by your doctor.
    • For juvenile idiopathic arthritis:
      • Children 4 years of age and older weighing 30 kilograms (kg) or more—40 milligrams (mg) injected under the skin every other week.
      • Children younger than 4 years of age weighing less than 30 kg—Use and dose must be determined by your doctor.
    • For plaque psoriasis:
      • Adults—At first, 80 milligrams (mg) injected under the skin, then 40 mg 1 week after the initial dose and every other week thereafter.
      • Children—Use and dose must be determined by your doctor.
    • For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:
      • Adults—40 milligrams (mg) injected under the skin every other week. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For ulcerative colitis:
      • Adults—At first (Day 1), 160 milligrams (mg) injected under the skin (four 40 mg injections in one day or two 40 mg injections a day for two days). Then 2 weeks later (Day 15), a dose of 80 mg is given. A maintenance dose of 40 mg is given at week 4 (Day 29) and every other week thereafter.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of adalimumab-adbm, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep it in its original container. Protect from light. You may also store adalimumab-adbm at room temperature for up to 14 days. Throw away any unused medicine after 14 days.

Throw away used syringes or pens in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using adalimumab-adbm

It is very important that your doctor check the progress of you or your child at regular visits to make sure adalimumab-adbm is working properly. Blood tests may be needed to check for unwanted effects.

You or your child will need to have a skin test for tuberculosis before you start using adalimumab-adbm. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Adalimumab-adbm injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Adalimumab-adbm may cause other unwanted effects that may not occur until months or years after adalimumab-adbm is used. A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (eg, leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Adalimumab-adbm injection may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using adalimumab-adbm.

Check with your doctor right away if you or your child have more than one of these symptoms: shortness of breath, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

Some people who have used adalimumab-adbm developed lupus-like symptoms during treatment and got better after the medicine was stopped. Check with your doctor right away if you or your child start having chest pains, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.

Do not have any live vaccines (immunizations) while you or your child are being treated with adalimumab-adbm. Your child's vaccines need to be current before he or she begins using adalimumab-adbm. Be sure to ask your child's doctor if you have any questions about this.

Adalimumab-adbm Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty in breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common

  • Abnormal healing
  • anxiety
  • black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blue or pale skin
  • blurred vision
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • dark urine
  • decreased vision
  • diarrhea
  • dizziness
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hoarseness
  • indigestion
  • itching
  • light-colored stools
  • loss of appetite
  • loss of strength or energy
  • muscle pain or weakness
  • nausea
  • pain in the throat, arms, legs, or pelvis
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • rapid weight gain
  • rash
  • severe nausea or vomiting
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • sweating
  • tingling of the hands or feet
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting
  • vomiting of blood
  • weakness
  • yellow eyes or skin

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • constipation
  • darkened urine
  • indigestion
  • itching joint or muscle pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • red, irritated eyes
  • red skin lesions, often with a purple center

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Incidence not known

  • Hair loss, thinning of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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