Hadlima (Subcutaneous)

Adalimumab-bwwd injection is used to treat symptoms and prevent the progression of moderate to severely active rheumatoid arthritis and active ankylosing spondylitis. It is used in children 2 years of age and older for 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-bwwd may be used alone or with other medicines (for example, methotrexate).

Adalimumab-bwwd injection is also used to treat moderate to severe active Crohn's disease. It is also used to treat moderate to severe ulcerative colitis.

Adalimumab-bwwd 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.

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

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

Adalimumab-bwwd injection will reduce the number of certain types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help prevent these issues, avoid being around people who are sick or have infections. Wash your hands frequently. Stay away from contact sports or other situations where you could get bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, such as razors and fingernail clippers.

This medicine may cause other unwanted effects that might 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 to 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 develops red, scaly patches, or raised bumps that are filled with pus.

Adalimumab-bwwd 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, trouble swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, genitals, rash, itching, trouble breathing, or unusual tiredness or weakness after receiving the medicine.

Contact your doctor immediately if you or your child experience 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 receive any live vaccines (immunizations) while you or your child are being treated with adalimumab-bwwd. Your child's vaccines should be up to date 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 you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision will be made by you and your doctor. For this medicine, you should consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any pediatric-specific issues that would limit the use of adalimumab-bwwd injection for treating juvenile idiopathic arthritis in children aged 2 years and older and for treating Crohn's disease in children aged 6 years and older. However, safety and effectiveness have not been established in children younger than 2 years for juvenile idiopathic arthritis, in children younger than 6 years for Crohn's disease, and in children for other conditions.

Geriatric

Studies done so far have not shown any geriatric-specific issues that would limit the use of adalimumab-bwwd injection in older adults. However, this medicine may cause serious infections and cancer more often in older adults, so caution may be needed for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during 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. If you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take 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 at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, 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 number of white blood cells) 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 developing new cancers.

• Diabetes or
• Hepatitis B, history of or
• Opportunistic infections, history of or
• Tuberculosis, history of—May increase the chance 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 adverse effects may occur, if they do occur they may need medical attention.

Check with your clinician right away if any of the following side effects occur:

More frequent

• Bladder pain
• bloody or cloudy urine
• blurred vision
• chest pain or tightness
• chills
• cough
• difficult, burning, or painful urination
• light-headedness
• ear congestion or pain
• fever
• frequent urge to urinate
• head congestion
• headache
• hoarseness or other voice changes
• lower back or side pain
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing

Less frequent

• Abnormal healing
• agitation
• anxiety
• arm, back, jaw pain
• bleeding from the gums or nose
• blindness
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or black, tarry stools
• bloody or cloudy urine
• blue or pale skin
• bone pain or fractures
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, tightness, or heaviness
• coma
• confusion
• cough or hoarseness
• dark urine
• decreased vision
• depression
• diarrhea
• difficulty in moving
• difficulty in swallowing
• sleepiness
• dry mouth
• dry skin
• eye pain
• fainting
• feeling of illness
• frequent urge to urinate
• gaseous stomach pain
• hair loss
• hallucinations
• heartburn
• increased thirst
• increased urination
• indigestion
• irritability
• itching, skin rash
• loss of appetite
• loss of strength or energy
• light-colored stools
• lower back or side pain
• mood or mental changes
• muscle pain, stiffness, cramps, tightness, rigidity, or spasms
• nausea
• no blood pressure or pulse
• pain, swelling, or redness in the joints
• pain in the arms or legs
• pain in the groin or genitals
• pain or burning in the throat
• painful or difficult urination
• pale skin
• pelvic pain
• rapid breathing
• rapid weight gain or loss
• recurrent fever
• redness or swelling of the lower leg
• ringing in the ears
• unconsciousness
• seizures
• shakiness in the legs, arms, hands, or feet
• sharp back pain just below ribs
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stiff neck
• stomach pain
• stopping of the heart
• sunken eyes
• sweating
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• trouble thinking
• unpleasant breath odor
• unusual bleeding or bruising
• unusual weight gain or loss
• visual disturbances
• vomiting
• vomiting of blood or material that looks like coffee grounds
• wrinkled skin
• yellow eyes or skin

Incidence not known

• Blindness
• blistering, peeling, or loosening of the skin
• decreased urine output
• decreased vision
• dilated neck veins
• irregular breathing
• irregular heartbeat
• red, irritated eyes
• red skin lesions, often with a purple center
• swelling of the face, fingers, feet, or lower legs
• unusual fatigue or weakness
• weight gain

Some adverse effects may occur that typically do not need 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 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

• 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 adverse 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 guidance about adverse effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Hadlima

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 Hadlima.

Humira (adalimumab) - AbbVie Inc.

View Humira information in detail.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a chemist 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 guidance in detail.

Amjevita (adalimumab-atto) - Amgen Inc.

View Amjevita details in detail.

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

View Cyltezo details in detail.

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

Hulio (adalimumab-fkjp) - Biocon Biologics Inc.

View Hulio information in detail.

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 information in detail.

This medicine is given as a shot under your skin in 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, or areas with scars or stretch marks.

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 brown. Do not use the syringe if it is cloudy, discolored, or has particles in it.

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 autoinjector): For Crohn's disease: Adults and children 6 years of age and older 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 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 at week 4 (Day 29) and every other week thereafter. Children 6 years of age weighing 17 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) 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 (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 to less than 30 kg—20 mg injected under the skin every other week. Weighing 10 to less than 15 kg—10 mg injected under the skin every other week. Children younger than 2 years of age or weighing less than 10 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 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 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. Throw away any unused medicine after 14 days. Do not store this medicine in extreme heat or cold temperatures.

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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