Adalimumab Subcutaneous

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

adalimumab comes with a Medication Guide and a Patient Instructions for Use leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use adalimumab 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.

adalimumab is available in 2 forms. You may use a Pen or a prefilled syringe.

To use thepen or syringe:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
• Wash your hands with soap and water before and after using adalimumab.
• Remove the carton with the syringe or pen from the refrigerator and place it on the cloth.
• Allow 15 to 30 minutes for the syringe or pen to warm up to room temperature. Do not warm adalimumab in any other way.
• Do not remove the needle cover on the prefilled syringe or pen while allowing the medicine to reach room temperature. Remove these immediately before use.
• Check the liquid in the syringe or pen using the viewing window. It should be clear and colorless. If it is cloudy, discolored, or has particles floating in it, do not use the syringe or pen.
• Check that the amount of liquid in the pen is the same or close to the fill line seen on the window. The fill line shows a full dose of the medicine. If the pen does not have the full amount of liquid, do not use it. Call your pharmacist.
• If the liquid is clear, place it on a clean, flat surface. Do not shake the medicine.
• Check the expiration date on the prefilled syringe or pen, and make sure the date has not passed. Do not use the medicine if the date has passed.
• Choose an injection site on your body (eg, thigh, abdomen or stomach area). Clean the injection site with a fresh alcohol wipe and let it dry.
• Remove the cap or needle cover when you are ready to inject. Inject the full amount of medicine within a few minutes after the cap or cover has been removed.
• Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Do not inject into skin areas that are red, bruised, tender, or hard. If you have psoriasis, do not inject into a raised, thick, red, or scaly skin patch or into skin lesions.
• You might have a small amount of blood or liquid at the injection site. Press and hold a dry, clean cotton ball on the injection site for 10 seconds, but do not rub it.
• Throw away used syringes or pens in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Dosing

The dose of adalimumab 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. 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 (pen or prefilled syringe):
  • For Crohn's disease:
    • Adults and children 6 years of age and older weighing 40 kilograms (kg) or more—At first (week 0), 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, a dose of 80 mg is given. A maintenance dose of 40 mg is given at week 4 and every other week thereafter.
    • Children 6 years of age and older weighing 17 kg and less than 40 kg—At first (week 0), 80 mg injected under the skin in divided doses. This may be given as two shots in 1 day. Then 2 weeks later, a dose of 40 mg is given. A maintenance dose of 20 mg is given at week 4 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 (week 0), 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, a dose of 80 mg is given. A weekly maintenance dose of 40 mg is given starting at week 4.
    • Children—Use and dose must be determined by your doctor.
  • For 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 between 15 to less than 30 kg—20 mg injected under the skin every other week.
    • Children 2 to 17 years of age weighing between 10 to less than 15 kg—10 mg injected under the skin every other week.
    • Children younger than 2 years of age—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 psoriatic arthritis, rheumatoid 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 (week 0), 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, a dose of 80 mg is given. A maintenance dose of 40 mg is given at week 4 and every other week thereafter.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of adalimumab, 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.

Protect the medicine from direct light. Keep your medicine and supplies in the original packages until you are ready to use them. Also, when traveling, store the medicine in a cool carrier with an ice pack.

If you will be using adalimumab for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if adalimumab is working properly and to decide whether you should continue to use it. 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. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Adalimumab can temporarily lower the number of white blood cells in your blood, which may increase the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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

adalimumab may cause other unwanted effects that may not occur until months or years after adalimumab 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 may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, swelling of the face, throat, legs, or feet, troubled breathing, or chest pain after you receive the medicine.

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 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. Your child's vaccines need to be current before he or she begins using adalimumab. Be sure to ask your child's doctor if you have any questions about this.

The needle cover of the prefilled syringe contains 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 you start using adalimumab.

Serious skin reactions can occur during treatment with adalimumab. Check with your doctor right away if you or your child have any of the following symptoms while using adalimumab: blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using adalimumab.

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:

• Abdominal or stomach fullness
• body aches or pain
• cough or hoarseness
• ear congestion
• gas with abdominal or stomach pain
• lightheadedness
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• pain or tenderness around the eyes or cheekbones
• rapid and sometimes shallow breathing
• shivering
• sunken eyes
• thirst
• trouble sleeping
• warmth on the skin
• wrinkled skin

• Abdominal or stomach pain
• abnormal vaginal bleeding or discharge
• agitation
• arm, back, or jaw pain
• black, tarry stools
• bleeding from the gums or nose
• blindness
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the stool or change in bowel habits
• bloody or cloudy urine
• blurred vision
• broken bones
• change in size, shape, or color of an existing mole
• change in skin color
• chest pain
• chest tightness or heaviness
• chills
• clear or bloody discharge from the nipple
• cold hands and feet
• confusion
• constipation
• cough
• coughing or spitting up blood
• decreased urination
• decreased vision
• depression
• difficult or frequent urination
• difficulty with breathing
• difficulty, burning, or painful urination
• dimpling of the breast skin
• dizziness
• drowsiness
• eye pain
• fainting
• fast, slow, or irregular heartbeat
• fever
• forgetfulness
• frequent urge to urinate
• general feeling of illness
• hair loss
• hallucinations
• headache
• increased thirst
• inverted nipple
• irregular breathing
• irregular pulse
• irritability
• itching or rash
• light colored stools
• loss of appetite
• lump in the breast or under your arm
• lump or swelling in the abdomen or stomach
• mole that leaks fluid or bleeds
• muscle cramps or spasms
• nausea
• new mole
• night sweats
• no blood pressure or pulse
• noisy breathing
• numbness or tingling in your arms, legs, or face
• pain, redness, or swelling in the arms or legs without any injury present
• pale skin
• persistent non-healing sore on your skin
• pink growth
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised, firm, or bright red patch
• redness or swelling of the breast
• seizures
• sharp back pain just below your ribs
• shiny bump on your skin
• slurred speech or problems with swallowing
• sneezing
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots on the lips or mouth
• spitting up blood
• stiff neck
• stopping of the heart
• sudden high fever or low grade fever for months
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• swollen neck veins
• tightness in the chest
• tiredness
• trouble breathing with activity
• trouble thinking
• unconsciousness
• unexplained bruising or bleeding
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• visual disturbances
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow skin or eyes

• Blistering, peeling, or loosening of the skin
• diarrhea
• joint or muscle pain
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• unusual bleeding or bruising

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:

• Bladder pain
• bleeding
• burning
• coldness
• discoloration of the skin
• feeling of pressure
• general feeling of discomfort or illness
• hives
• lumps
• numbness
• pounding in the ears
• redness
• scarring
• soreness
• stinging
• swelling
• tenderness
• tingling
• ulceration
• warmth

• Abnormal healing
• decrease in height
• difficulty with moving
• difficulty with swallowing
• difficulty with walking
• dry mouth
• heartburn
• indigestion
• loss of hearing
• loss of strength or energy
• menstrual changes
• muscle or joint stiffness, tightness, or rigidity
• muscle pain or weakness
• pain in the back, ribs, arms, or legs
• shakiness in the legs, arms, hands, and feet
• sores
• stomach pain, fullness, or discomfort
• swelling or redness in the joints
• weakness

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.

See also Warning section.

Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you develop signs of infection while using this drug, such as: sore throat that doesn't go away, cough that doesn't go away, fever, chills, night sweats, trouble breathing, painful or frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, unusual tiredness, fast/irregular/pounding heartbeat, blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, leg pain or swelling, numbness or tingling of the arms/hands/legs/feet, unsteadiness, unexplained muscle weakness, difficulty with speaking/chewing/swallowing/facial movements, vision changes, joint pain, butterfly-shaped rash on the nose and cheeks.

Adalimumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

Get medical help right away if you have any very serious side effects, including: seizures, chest pain.

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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), 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: current/recent/repeated infections (such as hepatitis B, TB infection, histoplasmosis), blood/bone marrow problems (such as low red/white blood cells and platelets), seizures, certain brain/nerve disorders (such as multiple sclerosis, Guillain-Barre syndrome), cancer, heart disease (especially heart failure), lupus.

Adalimumab can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

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

Older adults may be at greater risk for infections while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

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