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Adalimumab-aacf (Subcutaneous)

Generic name: adalimumab-aacf [ ay-da-LIM-ue-mab-- aacf ]
Brand name: Idacio
Drug classes: Antirheumatics, TNF alfa inhibitors

Medically reviewed by Drugs.com. Last updated on Feb 22, 2024.

Subcutaneous route(Solution)

Serious Infections

Patients treated with adalimumab products including adalimumab-aacf are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue adalimumab-aacf if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aacf use and during therapy. Initiate treatment for latent TB prior to adalimumab-aacf use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with adalimumab-aacf prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aacf, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Malignancy

Lymphoma 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 been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants .

Uses for adalimumab-aacf

Adalimumab-aacf 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 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-aacf may be used alone or in combination with other medicines (eg, methotrexate).

Adalimumab-aacf injection is also used to treat moderate to severe 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-aacf 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 adalimumab-aacf

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of adalimumab-aacf injection for the treatment of juvenile idiopathic arthritis in children 2 years of age and older and 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 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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adalimumab-aacf 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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

Proper use of adalimumab-aacf

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, stretch marks, or tattoos.

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 yellow. Do not use the syringe if it is cloudy, discolored, or has flakes or particles in it. Do not use the prefilled syringe or pen if it has been damaged or broken.

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.

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 28 days. Do not store it in extremely cold or hot temperatures. Throw away any unused medicine after 28 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.

Detailed Adalimumab dosage information

Precautions while using adalimumab-aacf

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-aacf 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.

Do not take other medicines unless they have been discussed with your doctor. Using abatacept (Orencia®), anakinra (Kineret®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), or infliximab (Remicade®) together with this medicine may increase your risk of having serious side effects.

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-aacf 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 using this medicine.

Check with your doctor right away if you or your child has 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 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-aacf. 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 adalimumab-aacf

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

Less common

Incidence not known

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

Incidence not known

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.

Adalimumab side effects (more detail)

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Antirheumatic

Pharmacologic Class: Adalimumab

Frequently asked questions

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Further information

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