Pronunciation:

ay-da-LIM-ue-mab - afzb

Brand Names:

• ABRILADA

Dosage Forms:

• Solution

Warnings:

Serious InfectionsIncreased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Discontinue adalimumab-afzb if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab-afzb.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products .

Classifications:

Therapeutic—

Antirheumatic

Pharmacologic—

Adalimumab

Uses of This Medicine:

Adalimumab-afzb 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 2 years of age and older for juvenile idiopathic arthritis. This medicine 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-afzb may be used alone or in combination with other medicines (eg, methotrexate).

Adalimumab-afzb injection is also used to treat moderate to severe active Crohn's disease. It is also used to treat 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-afzb injection is also used to treat moderate to severe chronic plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is given to patients who may receive other types of treatment, including pills, injection, or phototherapy (light treatment). It is also used to treat moderate to severe hidradenitis suppurativa, a chronic skin disease that causes small, painful lumps under the skin.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of adalimumab-afzb injection for the treatment of juvenile idiopathic arthritis in children 2 years of age and older and for thetreatment of Crohn's disease in children 6 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, in children younger than 6 years of age for Crohn's disease, and in children for other conditions.

Older adults—

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

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.

Other 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 this medicine, 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 this medicine 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
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Cholera Vaccine, Live
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Levoketoconazole
• Measles Virus Vaccine, Live
• Methotrexate
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rilonacept
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Theophylline
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Vedolizumab
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

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 this medicine. 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 this medicine.

Proper Use of This Medicine:

This medicine 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 this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

This medicine 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 this medicine 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. Do not inject into skin areas that are red, bruised, tender, hard, or scaly, or areas with scars or stretch marks. If you have psoriasis, do not inject into a raised, thick, red, or scaly skin patch or into skin lesions.

Allow 15 to 30 minutes for the medicine to warm up to room temperature. Do not remove the needle cover 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 pale brown. Do not use the syringe if it is cloudy, discolored, or has particles in it.

Dosing—

The dose of this medicine 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 this medicine. 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 or pen):
  • For Crohn's disease:
    • Adults and children 6 years of age and older weighing 40 kilograms (kg) or more—At first (Day 1), 160 milligrams (mg) injected under the skin in divided doses. This may be given as four shots in 1 day or as two shots per day for 2 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 6 years of age weighing 17 kg to less than 40 kg—At first (Day 1), 80 mg injected under the skin. Then 2 weeks later (Day 15), a dose of 40 mg is given. A maintenance dose of 20 mg is given at week 4 (Day 29) and every other week thereafter.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For hidradenitis suppurativa:
    • Adults—At first (Day 1), 160 milligrams (mg) injected under the skin. This may be given as four shots in 1 day or as two shots per day for 2 days. Then 2 weeks later (Day 15), a dose of 80 mg is given. A maintenance dose of 40 mg is given every week or 80 mg every other week at week 4 (Day 29).
    • Children—Use and dose must be determined by your doctor.
  • For juvenile idiopathic arthritis:
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing 30 kilograms (kg) or more—40 milligrams (mg) injected under the skin every other week.
      • Weighing 15 kg to less than 30 kg—20 mg injected under the skin every other week.
      • Weighing 10 to less than 15 kg—10 mg injected under the skin every other week.
    • Children younger than 2 years of age or weighing less than 10 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 as 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 this medicine, 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. Do not use it if it has been frozen or thawed. If needed (eg, traveling), you may also store this medicine at room temperature for up to 30 days. Do not store it in extremely cold or hot temperatures. Throw away any unused medicine after 30 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 This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine 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 this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Do not take other medicines unless they have been discussed with your doctor. Using abatacept (Orencia®) or anakinra (Kineret®) together with this medicine may increase your risk of having serious side effects.

Adalimumab-afzb 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.

This medicine may cause other unwanted effects that may not occur until months or years after this medicine 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-afzb injection may cause serious allergic reactions (eg, anaphylaxis, angioneurotic edema), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after using this medicine.

Check with your doctor right away if you or your child has swelling of the face, fingers, feet, or lower legs, sudden weight gain, or trouble breathing. These may be signs of a heart condition called congestive heart failure (CHF).

Some people who have used this medicine 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, 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-afzb. Your child's vaccines need to be current before he or she begins using this medicine. Be sure to ask your child's doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

chest pain or tightness

chills

cough

difficult, burning, or painful urination

ear congestion or pain

fever

frequent urge to urinate

head congestion

headache

hoarseness or other voice changes

lower back or side pain

pain or tenderness around the eyes and cheekbones

sneezing

sore throat

stuffy or runny nose

trouble breathing

Less common

Black, tarry stools

blindness

blue or pale skin

blurred vision

bone fractures

confusion

difficulty with moving

dizziness

fast, slow, or irregular heartbeat or pulse

increased thirst

increased urination

itching, skin rash

indigestion

light-colored stools

loss of appetite

loss of strength or energy

muscle pain or stiffness

nervousness

pain in the arms or legs

pounding in the ears

seizures

slow or fast heartbeat

sores, ulcers, or white spots on the lips or in the mouth

trouble thinking

unpleasant breath odor

unusual bleeding or bruising

vomiting

vomiting of blood

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

decreased urine output

diarrhea

dilated neck veins

irregular breathing

irregular heartbeat

itching

numbness or tingling in the fingers, face, or feet

red, irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

swelling of the face, fingers, feet, or lower legs

unusual tiredness or weakness

weight gain

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 the 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 or thinning of the 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.