WARNING

A serious infection, such as a severe fungal, bacterial, or viral infection that could spread throughout the body, is more likely to develop if you use adalimumab injection products. This is because your body’s ability to fight infection may be reduced. These infections might require medical treatment, and they might even be fatal. Inform your doctor if you frequently contract any kind of infection or if you already have or suspect you may have any kind of infection. This includes mild infections (like little cuts or sores), recurring infections (like cold sores), or persistent, chronic infections.

Throughout and after your treatment, your doctor will keep an eye out for any infections. Call your doctor right away if you suffer any of the following symptoms before your treatment starts, while it is being administered, or just afterward: Sweating, a sore throat, a cough that produces bloody mucus, a fever, excessive exhaustion, diarrhea, stomach pain, warm, red, or painful skin, painful, difficult, or frequent urination, or other infection-related symptoms.

You might already have hepatitis B (a virus that damages the liver) or tuberculosis (TB; a deadly lung infection), but show no signs of the illnesses. In this instance, adalimumab injectable products may raise your risk of developing symptoms and a more serious illness. Your doctor may request a blood test to determine whether you have an inactive hepatitis B infection in addition to performing a skin test to determine whether you have a TB infection. Before you start your adalimumab treatment, your doctor may, if required, give you medication to treat this infection. Inform your doctor if you have or have ever had tuberculosis, if you have ever lived in or visited a country where tuberculosis is prevalent, or if you have ever been near someone who has or has ever had the disease.

When given adalimumab injection products or comparable drugs, some kids, teens, and young adults experienced the onset of severe or life-threatening malignancies, such as lymphoma (a cancer that starts in the immune system cells that fight infection). Adalimumab or comparable drugs caused some male teenagers and young adults to develop hepatosplenic T-cell lymphoma (HSTCL), a highly dangerous cancer that frequently results in death within a short period of time.The majority of those who developed HSTCL were taking adalimumab or a similar medication along with another drug called azathioprine (Imuran) or 6-mercaptopurine (Purinethol) to treat ulcerative colitis or Crohn’s disease, conditions that cause swelling and sores in the lining of the colon (large intestine) and rectum and cause pain, diarrhea, weight loss, and fever.

Why is this medication prescribed?

The following autoimmune illnesses (disorders in which the immune system assaults healthy portions of the body and results in pain, swelling, and destruction) can be treated with adalimumab injectable products alone or in combination with other medications:

• Adults with rheumatoid arthritis, a condition in which the body assaults the joints, might experience pain, swelling, and functional loss in their joints.
• Children 2 years of age and older who have juvenile idiopathic arthritis (JIA), a condition in which the body attacks its own joints, might experience discomfort, swelling, loss of function, and delays in growth and development.
• In adults and children aged 6 and older with Crohn’s disease, the body assaults the lining of the digestive tract, resulting in discomfort, diarrhea, weight loss, and fever, and the condition does not get better when treated with other drugs,
• When earlier medications and therapies did not work or could not be tolerated, ulcerative colitis (a disorder that causes swelling and ulcers in the lining of the colon [large intestine] and rectum) in adults and children 5 years of age and older,
• In people with ankylosing spondylitis, the body assaults the joints in the spine and other parts of the body, resulting in discomfort and joint degeneration.
• Adults with psoriatic arthritis, which causes joint discomfort, edema, and skin scales,
• Hidradenitis suppurativa, a skin condition that affects adults and children 12 years of age and older and results in pimple-like pimples in the armpits, groin, and anal area,
• Uveitis, which affects adults and children 2 years of age and older and causes swelling and inflammation in several eye regions,Adults with persistent plaque psoriasis, a skin condition that causes red, scaly patches to appear on certain body parts.

Tumor necrosis factor (TNF) inhibitors, which include adalimumab injectable medicines, are a class of drugs. They function by preventing TNF from doing its job as the body’s inflammatory agent.

How should this medicine be used?

Adalimumab injectable products are available as liquid solutions to be injected subcutaneously. Based on your health and age, your doctor will advise you as to how frequently to use adalimumab products. Mark the days you are scheduled to administer the medication on your calendar to help you remember to administer adalimumab injectable products. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Adalimumab injection should only be used as prescribed. Use it only as directed by your doctor, neither more nor less often.

Your doctor’s office will be where you receive your first dosage of adalimumab injectable products. After that, you can administer adalimumab injection products by yourself or with the help of a friend or relative. Read the enclosed written instructions before using any adalimumab injection products for the first time. To learn how to inject a medicine, ask your doctor or pharmacist to demonstrate it to you or the person doing the injecting.

Prefilled syringes, prefilled dosage pens, and prefilled autoinjectors are available for adalimumab injection products. Use each syringe, pen, or autoinjector only once, and inject the entire amount of solution it contains. Do not inject again, even if there is still some solution in the syringe, pen, or autoinjector after you have once done so. Put spent syringes, pens, and autoinjectors in a container that won’t puncture. How to get rid of the puncture-resistant container should be discussed with your doctor or pharmacist.

If you’re using a prefilled syringe or a dosing pen that has been chilled, set it down on a flat surface, leaving the needle cap on, and let it thaw to room temperature for 15 to 30 minutes before you’re ready to inject the drug. Never attempt to reheat the drug by putting it in a hot water bath, microwave, or any other device.

Adalimumab injection can be injected anywhere on the front of your thighs or stomach, with the exception of the two inches (5 cm) around your navel. Use a different place for each injection to lessen the possibility of discomfort or redness. Each injection should be administered at least 1 inch (2.5 cm) away from an area that has already been used. Keep a record of the locations where you have administered injections so that you won’t do so there again. Never administer an injection to skin that is irritated, bruised, red, or firm, or that has scars or stretch marks.

Before injecting, always check the adalimumab injection solution. Verify that the syringe, dosing pen, or autoinjector contains the right amount of liquid and that the expiration date has not past. To find out what your adalimumab injection product solution should resemble, consult the written instructions for usage. If a syringe, dosing pen, or autoinjector is out-of-date, doesn’t contain the right amount of liquid, or if the liquid doesn’t appear to be what is indicated in the use instructions written down, do not use it.

Although they may aid in controlling your illness, adalimumab injectable products cannot heal it. Even if you feel better, keep using adalimumab injection products. Avoid stopping the use of adalimumab injectable products without first consulting your doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Regarding special precautions for Humira, here are some general guidelines to consider:

• Adalimumab, any other medications, or any of the substances in adalimumab injection products should all be disclosed to your doctor and pharmacist if you have any of these allergies. A list of the ingredients is available by asking your pharmacist or looking in the medication guide. If you want to use a prefilled syringe, make sure your doctor is aware of any latex or rubber allergies you may have, as well as those of the person helping you administer the adalimumab injection.
• As you use adalimumab injection, be sure to let your doctor and pharmacist know about all prescription and non-prescription drugs, vitamins, herbal items, and nutritional supplements that you are taking or intend to use. The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects.
• Inform the surgeon or dentist that you use adalimumab injection products if you are having surgery, including dental surgery.
• Inform your doctor if you are nursing a child or want to become pregnant. Adalimumab injection products should not be used if you get pregnant.
• Without consulting your doctor, avoid getting any immunizations. If your child will be taking adalimumab injection products, be sure that before starting therapy with adalimumab injection products, your child has got all the vaccinations recommended for kids his or her age.
• Tell your doctor if you have or have ever had, in addition to the conditions listed in the IMPORTANT WARNING section, numbness or tingling in any part of your body, any disease that affects your nervous system, such as multiple sclerosis (a condition where the nerves don’t function properly, causing weakness, numbness, loss of muscle coordination, problems with vision, speech, and bladder control), Guillain-Barré syndrome (weakness, tingling, Inform your doctor if light therapy has been used to treat your psoriasis if you have.

What special dietary instructions should I follow?

Keep eating the same way as usual unless your doctor instructs you otherwise.

What should I do if I forget a dose?

As soon as you recall, inject the missed dose. On the next day, as scheduled, administer the subsequent dose. To continue with your regular dosing plan, skip the missed dose if it is almost time for the next one. To make up for a missing dose, don’t take two.

What side effects can this medication cause?

Products containing adalimumab for injection may have adverse effects. If any of these symptoms are severe or do not go away, consult your doctor right once:

• Redness, itching, bruising, pain, or swelling in the place you injected adalimumab injection
• Nausea
• Headache
• Back pain

There are several negative effects that can be very harmful. Call your doctor right away or seek emergency care if you see any of the symptoms below or those in the IMPORTANT WARNING section:

• Numbness or tingling
• Problems with vision
• Weakness in legs
• Chest pain
• Shortness of breath
• Rash, especially a rash on the cheeks or arms that is sensitive to sunlight
• New joint pain
• Hives
• Itching
• Swelling of the face, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Fever, sore throat, chills, and other signs of infection
• Unusual bruising or bleeding
• Pale skin
• Dizziness
• Red, scaly patches or pus-filled bumps on the skin

In comparison to adults who do not receive adalimumab injectable products, those who do may be more likely to develop skin cancer, lymphoma, and other cancers. The dangers of using this drug should be discussed with your doctor.

What should I know about storage and disposal of this medication?

Storage of adalimumab injection:

Keep this medication tightly closed in the original container and out of the reach of children. Protect it from light and keep it in the refrigerator. Adalimumab injectable products shouldn’t be frozen. Any medication that has been frozen should be thrown away.

Adalimumab injection products can typically be kept for up to 14 days at room temperature (up to 77°F [25°C]) and away from light. These adalimumab injection items must be thrown away if they are kept at room temperature for more than 14 days without being used. More than 14 days’ worth of storage at room temperature is possible for some adalimumab injectable preparations. If you want to travel, discuss with your doctor how to preserve your medications.

Disposal of adalimumab injection:

To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department.

In case of emergency/overdose

• Accidental injection or overdose: If you or someone else accidentally injects too much adalimumab injectable or experiences severe side effects, seek immediate medical attention or contact your local poison control center.
• Symptoms of overdose: Symptoms may vary depending on the individual, but they could include severe headache, dizziness, nausea, vomiting, or increased risk of infections. It’s important to seek medical help if you suspect an overdose.

What other information should I know?

Do not miss any of your doctor’s or lab appointments. To assess how well your body is responding to adalimumab injection products, your doctor will prescribe a number of blood tests before, during, and after your therapy.

Never allow someone else to use your medication. If you have any queries regarding getting a prescription renewed, ask your pharmacist.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Additionally, it is crucial to have this knowledge on hand in case of emergency.

Remember, this information is not exhaustive, and it’s essential to consult the prescribing information and follow the guidance provided by your healthcare provider and the medication’s packaging.