Humira

What is Humira?

Humira, a tumor necrosis factor (TNF), is a TNF blocker that reduces the inflammation caused by a substance within the body.Humira can be used to treat a variety of inflammatory conditions, including rheumatoid and psoriatic joints, ankylosing spine, plaque psoriasis, and a skin disorder called hidradenitis suppurativa.Humira can also be used to treat Crohn’s disease in children and adults, juvenile arthritis, colitis ulcerative, and eye inflammation.

Side effects of Humira

If you experience any of the following symptoms of an allergic reaction: itching; difficulty breathing; swelling on your face, lips, or tongue; or swelling of the throat, face, or lips, seek emergency medical attention.

If you experience any of the symptoms of lymphoma, call your doctor immediately.

• Fever, swollen glands, night sweats, and a general feeling of illness;
• Joint and muscular pain; skin rash; easy bruising, bleeding, or tearing
• Pale skin, feeling faint or light-headed, cold hands and/or feet
• Pain in the upper abdomen that can spread to your shoulder
• Loss of appetite and feeling full even after eating a small portion.

Call your doctor immediately if you experience:

• Psoriasis, new or worsening
• A sore or bump that doesn't heal.
• Sepsis symptoms: confusion, chills, and severe drowsiness; rapid heartbeats and breathing; feeling very sick.
• Liver problems: body aches and fatigue, nausea, vomiting, loss of appetite, dark urine or stools with a clay color, jaundice (yellowing skin or eyes),
• Syndrome lupus: pain in the joints, swelling, chest discomfort, shortness of breath, and a patchy color of skin that gets worse when exposed to sunlight.
• Nerve problems: tingling or numbness; dizziness; vision problems; or weakness in the arms or legs.
• Signs of tuberculosis: fever with a persistent cough, weight loss

Adalimumab may increase the risk of cancer or infection in older adults.

Humira side effects may include:

• Headache;
• Cold symptoms, including stuffy noses, sinus pain, and a sneezing sore throat.
• Rash;
• Redness, bruising, or swelling at the site of injection

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Warnings

Humira can affect your immune system. Adalimumab may lower your immune system's ability to fight infection and make you more susceptible to infection. People taking this medication have experienced serious infections caused by bacteria, viruses, or fungi. These infections have caused some people to die.Tuberculosis is one of the most serious infections. You should be tested for TB by your doctor before and during Humira treatment.Tell your doctor, before or during the treatment, if you experience any signs of infection, such as fevers, chills or aches, fatigue, sores on the skin, diarrhea, or burning in your urination.

Before you take this drug

Humira should not be used if you have an allergy to adalimumab.Tell your doctor before you begin using this medication if you experience any signs of infection, such as fever, chills or sweats, muscle pain, fatigue, coughing up bloody mucus, or skin sores. Also, if you feel constantly tired, have diarrhea, are experiencing burning in your urination, or have a fever,Humira is not recommended for children younger than two years of age (or six years if it's being used to treat Crohn's disease). All childhood vaccinations should be up-to-date before beginning treatment.

Tell your doctor about any of the following:

• Tuberculosis
• A chronic infection
• Cancer;
• Hepatitis a adalimumab may cause hepatitis to return or worsen.
• Diabetes;
• Heart failure;
• Any tingling or numbness, or a disorder of the nerves and muscles, such as multiple sclerosis or guillain-barre syndrome
• Allergy to latex rubber
• If you have a major operation scheduled,
• If you recently received or have scheduled any vaccinations,

Tell your doctor if you plan to or have traveled recently. You could be exposed to diseases that are prevalent in certain parts of the world.Humira can cause a rare form of lymphoma, or cancer, of the liver, bone marrow, and spleen. This is more common in young men and teenagers with Crohn's disease and ulcerative colitis. Anyone with an autoimmune disease that is inflammatory may be at a greater risk for lymphoma. Speak to your doctor about the risk you face.This medicine is not known to harm an unborn child. Inform your doctor if you are pregnant. Tell any doctor who will be caring for your baby that you took adalimumab during pregnancy.You may not be able to breastfeed your baby if you are taking this medication. You should ask your doctor if there are any risks.

How to take Humira?

Follow the instructions on your prescription label and read all medication guides or instruction sheets. Read all the instructions and directions that come with your prescription. Follow the directions on the label.Humira can be injected into the skin. You will be taught how to use the medicine properly by a healthcare provider.Do not start taking this medication if you show any signs of infection. For instructions, call your doctor.Please read and follow all the instructions that come with your medication. Humira should not be used if the instructions are not understood. If you have questions, ask your pharmacist or doctor.Humira's dosage schedule is highly variable, and it depends on what condition you're treating. Do not forget to follow your doctor's instructions.Only prepare your injection when you're ready to administer it. If the medicine is cloudy or has a different color, it should not be used. For new medicine, call your pharmacist.Humira can affect your immune system. You could get more infections, including serious or deadly infections. Regular doctor's visits are necessary.

This medicine should be stored in the original container in a fridge. Do not freeze. When traveling, follow the instructions provided by your doctor for how to store your medication. Avoid extremes of heat or cold.Humira can be thrown away if it has frozen.Only use a needle or syringe once, and then store them in a "sharps container" that is puncture-proof. Be sure to follow local or state laws on how to properly dispose of the container. Keep the container out of reach of pets and children.Adult dose for rheumatoid arthritis:Every other week, 40 mg of subcutaneously administered vitamin D3 is recommended.For some patients who do not take methotrexate concomitantly, the dose interval can be increased by 40 mg per week.Concomitant administration of methotrexate may include glucocorticoids or salicylates. Nonsteroidal anti-inflammatory agents, analgesics, and other disease-modifying drugs can also be administered.

Details on dosage

Adult dose of Humira as usual for psoriatic arthritis:

Every other week, 40 mg of subcutaneously administered fluoxetine is recommended.
For some patients who do not take methotrexate concomitantly, the dose interval can be increased by 40 mg per week.

Concomitantly, methotrexate may be administered with glucocorticoids or salicylates. Nonsteroidal anti-inflammatory agents, analgesics, and other disease-modifying drugs can also be administered.

Adult dose for Crohn's disease—Acute:

Initial dose: 160 mg subcutaneously, Day 1.
The first dose can be administered as either 4 injections in the morning on Day 1 or 2 injections a day for two consecutive days (Days 1, and 2).
Week 2: 80 mg subcutaneously, on Day 15.
Maintenance dose: Starting week 4 (Day 29), 40 mg every two weeks.
Adalimumab can be used in conjunction with aminosalicylates (anti salicylates), corticosteroids, and/or immunomodulating agents.
Clinical trials evaluating the use of adalimumab beyond one year for Crohn's disease have not been conducted.

Adult dose of Humira: Maintenance:

Initial dose: 160 mg subcutaneously, Day 1.
The first dose can be administered as either 4 injections in the morning on Day 1 or 2 injections a day for two consecutive days (Days 1, and 2).
Week 2: 80 mg subcutaneously, on Day 15.
Maintenance dose: Starting week 4 (Day 29), 40 mg every two weeks.
Humira can be used in conjunction with aminosalicylates (amino acids), corticosteroids, and/or immunomodulatory drugs.
Clinical trials evaluating the use of adalimumab beyond one year for Crohn's disease have not been conducted.

Adult dose for ulcerative colitis:

Initial dose: 160 mg subcutaneously, Day 1.
The first dose can be administered as either 4 injections in the morning on Day 1 or 2 injections a day for two consecutive days (Days 1, and 2).
Week 2: 80 mg subcutaneously, on Day 15.
Maintenance dose: Starting week 4 (Day 29), 40 mg every two weeks.
Humira can be used in conjunction with aminosalicylates (amino acids), corticosteroids, and/or immunomodulatory drugs.
Clinical trials evaluating the use of adalimumab beyond one year for Crohn's disease have not been conducted.

Usual Adult Dose for Plaque Psoriasis:

Initial dose: 80 mg subcutaneously.
Maintenance dose: 40 mg subcutaneously every two weeks, starting one week following the initial dose.

Usual pediatric dose for juvenile idiopathic arthritis:

From 4 to 17 years:
Humira is only available in limited quantities for pediatric patients weighing less than 15 kg.
If you weigh between 15 kg (33 pounds) and 30 kg (66 pounds), Take 20 mg every two weeks.
If you weigh more than 30 kg (66 pounds), take 40 mg every two weeks.
Humira can be used in conjunction with methotrexate or other glucocorticoids. Salicylates are also an option.

What happens if I miss the dose?

Do not use extra medicine to make up for missed doses. You should not take extra medicine to compensate for a missed dose.

What happens if I overdose?

Call 1-800-222-1222 to get poison help. Or, seek immediate medical attention.

What should be avoided?

Humira should not be injected into skin that has been bruised, is red, tender, or hard.Avoid being around people who are ill or infected. If you notice any signs of an infection, tell your doctor immediately.Avoid receiving a "live vaccine" while taking adalimumab. This may cause the vaccine to not work properly and not protect you fully from disease. Live vaccines are available for measles (MMR), rubella, poliovirus, rotavirus (typhoid), yellow fever, typhoid (rotavirus), varicella (the chickenpox), or zoster( shingles).

Interaction with other drug

Adalimumab should not be taken with certain drugs. Tell your doctor all the medicines you take, including those you stop or start using during treatment with Humira.

• Abatacept, etanercept;
• Anakinra;
• Azathioprine, 6-mercaptopurine,
• Certolizumab, golimumab, infliximab, and rituximab.

This list is incomplete. Adalimumab may interact with other drugs, such as prescription and OTC medications, vitamins, and herbal supplements. This medication guide does not list all possible interactions.