Hulio (Subcutaneous)

Adalimumab-fkjp injection is used to treat the symptoms and prevent the worsening of moderate to severely active rheumatoid arthritis and active ankylosing spondylitis. It can be used in children 2 years and older for juvenile idiopathic arthritis. This medicine is also used to treat psoriatic arthritis, a type of arthritis that causes joint pain and swelling, along with patches of scaly skin on some parts of the body. Psoriatic arthritis often occurs with a skin condition called psoriasis. Adalimumab-fkjp may be used alone or together with other medicines (for example, methotrexate).

Adalimumab-fkjp injection is also used to treat moderate to severe active Crohn's disease. It is used to treat moderate to severe ulcerative colitis in patients who have received other treatments (such as azathioprine, corticosteroids, or 6-mercaptopurine) that did not work well.

Adalimumab-fkjp injection is also used to treat moderate to severe chronic plaque psoriasis, 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, injections, 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.

It is very important for your doctor to check your or your child's progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You or your child will need a skin test for tuberculosis before starting this medicine. Inform your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Adalimumab-fkjp injection will reduce 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 issues, avoid being around people who are sick or have infections. Wash your hands frequently. Stay away from rough sports or situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless your doctor has discussed them with you. Using abatacept (Orencia®) or anakinra (Kineret®) together with this medicine may increase your risk of serious side effects.

This medicine may cause other unwanted effects that may not appear until months or years after starting treatment. A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (e.g., leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child experience unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, contact your doctor immediately if your skin has red, scaly patches or raised bumps filled with pus.

Adalimumab-fkjp injection may cause serious allergic reactions (e.g., anaphylaxis, angioneurotic edema), which can be life-threatening and require immediate medical attention. Contact 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.

Contact your doctor right away if you or your child have more than one of these symptoms: 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 improved after stopping the medicine. Contact 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-fkjp. Your child's vaccines need to be current before starting 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.

In deciding to use this medicine, you and your doctor will weigh the risks of taking it against the benefits it may provide. Consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of adalimumab-fkjp injection for treating juvenile idiopathic arthritis in kids 2 years and older and for treating Crohn's disease in kids 6 years and older. However, safety and effectiveness have not been established in children younger than 2 years or weighing less than 10 kilograms (kg) for juvenile idiopathic arthritis, in children younger than 6 years for Crohn's disease, or in children for other conditions.

Geriatric

Studies done so far have not shown any specific problems in the elderly that would limit the use of adalimumab-fkjp injection. However, this medicine may cause serious infections and cancer more often in older adults, which may require caution for patients using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Blood problems (e.g., 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 white blood cell count) or
• Multiple sclerosis or
• Optic neuritis (eye problem) or
• Psoriasis (skin disease)—Use with caution. May worsen these conditions.

• Cancer, active or history of or
• Chronic obstructive pulmonary disease (COPD) or
• Granulomatosis with polyangiitis—Use with caution. May increase the risk of new cancers.

• Diabetes or
• Hepatitis B, history of or
• Opportunistic infections, history of or
• Tuberculosis, history of—May increase the risk for side effects.

• Infection, active—Should not be used in patients with this condition.

• Tuberculosis, active—Should be treated first before receiving this medicine.

Along with its needed effects, a drug may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Verify with your clinician immediately if any of the following adverse effects occur:

More common

• Bladder pain
• bloody or cloudy urine
• chest pain or tightness
• chills
• cough
• difficult, burning, or painful urination
• ear congestion or pain
• fever
• frequent urge to urinate
• headache
• hoarseness or other voice changes
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing

Less frequent

• Black, tarry stools
• blindness
• blurred vision
• bone fractures
• confusion
• constipation
• dark urine
• decreased vision
• difficulty with moving
• dizziness
• dry skin
• eye pain
• hair loss
• increased thirst
• increased urination
• itchiness, skin rash
• joint pain
• light-colored stools
• loss of appetite
• muscle cramps, pain, spasms, or stiffness
• nausea
• nervousness
• pain in the arms or legs
• pounding in the ears
• seizures
• slow or fast heartbeat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• trouble thinking
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• decreased urine output
• diarrhea
• dilated neck veins
• irregular breathing
• irregular heartbeat
• joint pain
• numbness or tingling in the fingers, face, or feet.
• red, irritated eyes
• red skin lesions, frequently with a purple center
• swelling of the face, fingers, feet, or lower legs
• weight gain

Some adverse effects may occur that usually do not require medical attention. These side effects may go away during therapy as your body adjusts to the medicine. As well, your health care professional may be capable to inform 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

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itchiness, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, verify 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.

In the U.S.

• Hulio

Available Dosage Forms:

• Solution

Therapeutic Class: Antirheumatic

Pharmacologic Class: Adalimumab

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Hulio.

Humira (adalimumab) - AbbVie Inc.

View Humira guidance in detail.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Abrilada (adalimumab-afzb) - Pfizer Inc.

View Abrilada information in detail.

Amjevita (adalimumab-atto) - Amgen Inc.

View Amjevita information in detail.

Cyltezo (adalimumab-adbm) - Boehringer Ingelheim Pharmaceuticals, Inc.

View Cyltezo details in detail.

Hadlima (adalimumab-bwwd) - Samsung Bioepis Co., Ltd.

View Hadlima guidance in detail.

Hulio (adalimumab-fkjp) - Biocon Biologics Inc.

Hyrimoz (adalimumab-adaz) - Sandoz Inc.

View Hyrimoz information in detail.

Simlandi (adalimumab-ryvk) - Alvotech USA Inc.

View Simlandi guidance in detail.

Yuflyma (adalimumab-aaty) - CELLTRION, Inc.

View Yuflyma information in detail.

Yusimry (adalimumab-aqvh) - Emerge Bioscience Pte. Ltd.

View Yusimry guidance in detail.

Humira biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Idacio (adalimumab-aacf) - Fresenius Kabi USA, LLC

View Idacio guidance in detail.

This medicine is given as a shot under the skin of the front of your 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, raised, thick, or areas with scars or stretch marks.

Allow 30 minutes for the medicine to warm up to room temperature. Do not put it back in the refrigerator after it has reached 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 prefilled syringe or pen. It should be clear and colorless to pale brownish-yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake. 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.

• For injection dosage forms (prefilled syringe or pen): For Crohn's disease: Adults—At first (Day 1), 160 milligrams (mg) injected under the skin. This may be given as four shots in 1 day or 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) every other week. Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. 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 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) every other week. 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) every other week. Children younger than 6 years of age or weighing less than 17 kg—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 juvenile idiopathic arthritis: Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. Weighing 30 kilograms (kg) or more—40 milligrams (mg) injected under the skin every other week. Weighing 15 kg 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. 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 two shots per day for two 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 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 store this medicine at room temperature for up to 14 days. Do not store it in extremely cold or hot temperatures. Throw away any unused medicine after 14 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.

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