Pronunciation:

ay-da-LIM-ue-mab - adbm

Brand Names:

• Cyltezo

Dosage Forms:

• Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antirheumatic

Pharmacologic—

Adalimumab

Uses of This Medicine:

Adalimumab-adbm injection is used to treat the symptoms and prevent the progression of moderate to severe rheumatoid arthritis and ankylosing spondylitis. It is used in children 2 years of age and older for moderate to severe polyarticular 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-adbm may be used alone or in combination with other medicines (eg, methotrexate).

Adalimumab-adbm injection is also used to treat moderate to severe Crohn's disease. It is also used to treat moderate to severe ulcerative colitis.

Adalimumab-adbm 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 also used to treat non-infectious intermediate, posterior, and panuveitis.

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-adbm injection for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older or for the treatment 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 for polyarticular 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-adbm 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.

To use the prefilled syringe or pen:

• Wash your hands with soap and water before and after using this medicine.
• Allow 15 to 30 minutes for the syringe or pen to warm up to room temperature.
• Do not remove the needle cover on the prefilled syringe or pen while allowing the medicine to reach to room temperature. Remove it before use.
• Check the liquid in the syringe or pen. It should be clear and colorless to slightly yellow. Do not use the medicine 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 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. 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 and older 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 polyarticular juvenile idiopathic arthritis:
    • Children 2 to 17 years of age weighing 30 kilograms (kg) or more—40 milligrams (mg) injected under the skin every other week.
    • Children 2 to 17 years of age weighing 15 to less than 30 kg—20 mg injected under the skin every other week.
    • Children younger than 2 years of age or weighing less than 15 kg—Use and dose must be determined by your doctor.
  • For plaque psoriasis or uveitis:
    • 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. Some patients with rheumatoid arthritis who are not taking methotrexate may use 40 mg every week or 80 mg every other week.
    • 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. 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—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 the medicine in its original carton to protect from light. Do not use it if it has been frozen or thawed. If needed (eg, traveling), you may store this medicine at room temperature for up to 14 days. Throw away any unused medicine after 14 days. Do not store this medicine in extreme heat or cold temperatures.

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 the progress of you or your child 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.

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.

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-adbm 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 a cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after you receive the medicine.

Check with your doctor right away if you or your child have 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, trouble breathing, 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 this medicine. Be sure to ask your child's doctor if you have any questions about this.

The needle cover of some prefilled syringes and pens contain dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before using this medicine.

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

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

runny or stuffy 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

hoarseness

indigestion

itching, skin rash

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

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

yellow eyes or skin

Incidence not known

Blindness

blistering, peeling, or loosening of the skin

blue-yellow color blindness

blurred vision

constipation

darkened urine

eye pain

indigestion

joint or muscle pain

pain, redness, or swelling in the arm or leg

pains in the stomach, side, or abdomen, possibly radiating to the back

red, irritated eyes

red skin lesions, often with a purple center

trouble breathing

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

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.