ABRILADA™ (adalimumab-afzb) 5 WARNINGS AND PRECAUTIONS

(adalimumab-afzb)

Prescribing Information

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

Patients treated with adalimumab products, including ABRILADA, are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections in patients with rheumatoid arthritis (RA); therefore, the concomitant use of ABRILADA and these biologic products is not recommended in the treatment of patients with RA [see Warnings and Precautions (5.7, 5.11) and Drug Interactions (7.2)].

Treatment with ABRILADA should not be initiated in patients with an active infection, including localized infections. Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating therapy in patients:

•: with chronic or recurrent infection;
•: who have been exposed to tuberculosis;
•: with a history of an opportunistic infection;
•: who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or
•: with underlying conditions that may predispose them to infection.

Tuberculosis

Cases of reactivation of tuberculosis and new onset tuberculosis infections have been reported in patients receiving adalimumab products, including patients who have previously received treatment for latent or active tuberculosis. Reports included cases of pulmonary and extrapulmonary (i.e., disseminated) tuberculosis. Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating ABRILADA and periodically during therapy.

Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Prior to initiating ABRILADA, assess if treatment for latent tuberculosis is needed; and consider an induration of ≥5 mm a positive tuberculin skin test result, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

Consider anti-tuberculosis therapy prior to initiation of ABRILADA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab products. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.

Strongly consider tuberculosis in the differential diagnosis in patients who develop a new infection during ABRILADA treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

Monitoring

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Tests for latent tuberculosis infection may also be falsely negative while on therapy with ABRILADA.

Discontinue ABRILADA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with ABRILADA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.

Invasive Fungal Infections

If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider appropriate empiric antifungal therapy, taking into account both the risk for severe fungal infection and the risks of antifungal therapy, while a diagnostic workup is being performed. To aid in the management of such patients, consider consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections.

5.2 Malignancies

Consider the risks and benefits of TNF-blocker treatment including ABRILADA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF blocker in patients who develop a malignancy.

Malignancies in Adults

In the controlled portions of clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies have been observed among TNF-blocker-treated adult subjects compared to control-treated adult subjects. During the controlled portions of 39 global adalimumab clinical trials in adult subjects with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS) and uveitis (UV), malignancies, other than non-melanoma (basal cell and squamous cell) skin cancer, were observed at a rate (95% confidence interval) of 0.7 (0.48, 1.03) per 100 patient-years among 7973 adalimumab-treated subjects versus a rate of 0.7 (0.41, 1.17) per 100 patient-years among 4848 control-treated subjects (median duration of treatment of 4 months for adalimumab-treated subjects and 4 months for control-treated subjects). In 52 global controlled and uncontrolled clinical trials of adalimumab in adult subjects with RA, PsA, AS, CD, UC, Ps, HS and UV, the most frequently observed malignancies, other than lymphoma and NMSC, were breast, colon, prostate, lung, and melanoma. The malignancies in adalimumab-treated subjects in the controlled and uncontrolled portions of the studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).1

In controlled trials of other TNF blockers in adult subjects at higher risk for malignancies (i.e., subjects with COPD with a significant smoking history and cyclophosphamide-treated subjects with Wegener's granulomatosis), a greater portion of malignancies occurred in the TNF blocker group compared to the control group.

Non-Melanoma Skin Cancer

During the controlled portions of 39 global adalimumab clinical trials in adult subjects with RA, PsA, AS, CD, UC, Ps, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated subjects and 0.2 (0.10, 0.59) per 100 patient-years among control-treated subjects. Examine all patients, and in particular patients with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment for the presence of NMSC prior to and during treatment with ABRILADA.

Lymphoma and Leukemia

In the controlled portions of clinical trials of all the TNF-blockers in adults, more cases of lymphoma have been observed among TNF-blocker-treated subjects compared to control-treated subjects. In the controlled portions of 39 global adalimumab clinical trials in adult subjects with RA, PsA, AS, CD, UC, Ps, HS and UV, 2 lymphomas occurred among 7973 adalimumab-treated subjects versus 1 among 4848 control-treated subjects. In 52 global controlled and uncontrolled clinical trials of adalimumab in adult subjects with RA, PsA, AS, CD, UC, Ps, HS and UV with a median duration of approximately 0.7 years, including 24,605 subjects and over 40,215 patient-years of adalimumab, the observed rate of lymphomas was approximately 0.11 per 100 patient-years. This is approximately three-fold higher than expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).1 Rates of lymphoma in clinical trials of adalimumab cannot be compared to rates of lymphoma in clinical trials of other TNF blockers and may not predict the rates observed in a broader patient population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Post-marketing cases of acute and chronic leukemia have been reported in association with TNF-blocker use in RA and other indications. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately two-fold) than the general population for the development of leukemia.

Malignancies in Pediatric Patients and Young Adults

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blockers (initiation of therapy ≤18 years of age), of which ABRILADA is a member. Approximately half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources including registries and spontaneous postmarketing reports.

Postmarketing 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 of these patients had received treatment with the immunosuppressants 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. The potential risk with the combination of azathioprine or 6-mercaptopurine and ABRILADA should be carefully considered.

5.3 Hypersensitivity Reactions

Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of ABRILADA and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed.

5.4 Hepatitis B Virus Reactivation

Use of TNF blockers, including ABRILADA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. For patients who are carriers of HBV and require treatment with TNF blockers, closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop ABRILADA and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of ABRILADA therapy in this situation and monitor patients closely.

5.5 Neurologic Reactions

Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of ABRILADA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of ABRILADA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders.

5.6 Hematological Reactions

Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., thrombocytopenia, leukopenia) have been infrequently reported with adalimumab products. The causal relationship of these reports to adalimumab products remains unclear. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on ABRILADA. Consider discontinuation of ABRILADA therapy in patients with confirmed significant hematologic abnormalities.

5.7 Increased Risk of Infection When Used with Anakinra

Concurrent use of anakinra (an interleukin-1 antagonist) and another TNF-blocker, was associated with a greater proportion of serious infections and neutropenia and no added benefit compared with the TNF-blocker alone in patients with RA. Therefore, the combination of ABRILADA and anakinra is not recommended [see Drug Interactions (7.2)].

5.8 Heart Failure

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Adalimumab products have not been formally studied in patients with CHF; however, in clinical trials of another TNF blocker, a higher rate of serious CHF-related adverse reactions was observed. Exercise caution when using ABRILADA in patients who have heart failure and monitor them carefully.

5.9 Autoimmunity

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions (6.1, 6.3)]. If a patient develops symptoms and findings suggestive of a lupus‑like syndrome or autoimmune hepatitis following treatment with ABRILADA, discontinue treatment and evaluate the patient.

5.10 Immunizations

In a placebo-controlled clinical trial of subjects with RA, no difference was detected in anti-pneumococcal antibody response between adalimumab and placebo treatment groups when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with adalimumab. Similar proportions of subjects developed protective levels of anti-influenza antibodies between adalimumab and placebo treatment groups; however, titers in aggregate to influenza antigens were moderately lower in subjects receiving adalimumab. The clinical significance of this is unknown. Patients on ABRILADA may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.

It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating ABRILADA therapy. Patients on ABRILADA may receive concurrent vaccinations, except for live vaccines.

The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants [see Use in Specific Populations (8.1, 8.4)].

5.11 Increased Risk of Infection When Used with Abatacept

In controlled trials, the concurrent administration of TNF-blockers and abatacept was associated with a greater proportion of serious infections than the use of a TNF-blocker alone; the combination therapy, compared to the use of a TNF-blocker alone, has not demonstrated improved clinical benefit in the treatment of RA. Therefore, the combination of abatacept with TNF-blockers including ABRILADA is not recommended [see Drug Interactions (7.2)].

Medication Guide

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MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2024
MEDICATION GUIDE ABRILADA™ (AH brill-ah-dah) (adalimumab-afzb) injection, for subcutaneous use
Read the Medication Guide that comes with ABRILADA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about ABRILADA? ABRILADA is a medicine that affects your immune system. ABRILADA can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections. • Your healthcare provider should test you for TB before starting ABRILADA. • Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA. You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay. Before starting ABRILADA, tell your healthcare provider if you: • think you have an infection or have symptoms of infection such as:
	o fever, sweats, or chills o muscle aches o cough o shortness of breath o blood in phlegm	o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinate more often than normal o feel very tired o weight loss
• are being treated for an infection. • get a lot of infections or have infections that keep coming back. • have diabetes. • have TB, or have been in close contact with someone with TB. • were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure. • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use ABRILADA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. • have or have had hepatitis B. • use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP). • are scheduled to have major surgery After starting ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection. ABRILADA can make you more likely to get infections or make any infection that you may have worse. Cancer • For children and adults taking tumor necrosis factor (TNF) blockers, including ABRILADA, the chances of getting cancer may increase. • There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. • People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. • If you use TNF blockers including ABRILADA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal. • Some people receiving TNF blockers including ABRILADA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).
What is ABRILADA? ABRILADA is a medicine called a tumor necrosis factor (TNF) blocker. ABRILADA is used: • To reduce the signs and symptoms of: o moderate to severe RA in adults. ABRILADA can be used alone, with methotrexate, or with certain other medicines. o moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. ABRILADA can be used alone or with methotrexate. o psoriatic arthritis (PsA) in adults. ABRILADA can be used alone or with certain other medicines. o ankylosing spondylitis (AS) in adults. o moderate to severe hidradenitis suppurativa (HS) in adults. • To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. • To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. • To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). • To treat non-infectious intermediate, posterior, and panuveitis in adults.
What should I tell my healthcare provider before taking ABRILADA? ABRILADA may not be right for you. Before starting ABRILADA, tell your healthcare provider about all of your medical conditions, including if you: • have an infection. See "What is the most important information I should know about ABRILADA?" • have or have had cancer. • have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome. • have or had heart failure. • have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using ABRILADA. Children should be brought up to date with all vaccines before starting ABRILADA. • are allergic to ABRILADA or to any of its ingredients. The ABRILADA prefilled syringe and prefilled pen are not made with natural rubber latex. See the end of this Medication Guide for a list of ingredients in ABRILADA. • are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take ABRILADA while you are pregnant or breastfeeding. • have a baby and you were using ABRILADA during your pregnancy. Tell your baby's healthcare provider before your baby receives any vaccines. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use: • ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use ABRILADA while you are also using one of these medicines. • RITUXAN (rituximab). Your healthcare provider may not want to give you ABRILADA if you have received RITUXAN (rituximab) recently. • IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP). Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take ABRILADA? • ABRILADA is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of ABRILADA. This is based on your condition to be treated. Do not inject ABRILADA more often than you were prescribed. • See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject ABRILADA. • Make sure you have been shown how to inject ABRILADA before you do it yourself. You can call your healthcare provider or 1-800-438-1985 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject ABRILADA. • Do not try to inject ABRILADA yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA. • Do not miss any doses of ABRILADA unless your healthcare provider says it is okay. If you forget to take ABRILADA, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject ABRILADA, call your healthcare provider or pharmacist. • If you take more ABRILADA than you were told to take, call your healthcare provider.
What are the possible side effects of ABRILADA? ABRILADA can cause serious side effects, including: See "What is the most important information I should know about ABRILADA?" • Serious Infections. Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ABRILADA and during treatment with ABRILADA. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking ABRILADA. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking ABRILADA:
	o cough that does not go away o low grade fever	o weight loss o loss of body fat and muscle (wasting)
• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ABRILADA. Your healthcare provider should do blood tests before you start treatment, while you are using ABRILADA, and for several months after you stop treatment with ABRILADA. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
	o muscle aches o feel very tired o dark urine o skin or eyes look yellow o little or no appetite o vomiting	o clay-colored bowel movements o fever o chills o stomach discomfort o skin rash
• Allergic reactions. Allergic reactions can happen in people who use ABRILADA. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:
	o hives o trouble breathing	o swelling of your face, eyes, lips or mouth
• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. • Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. • New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking ABRILADA, including:
	o shortness of breath o sudden weight gain	o swelling of your ankles or feet
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop ABRILADA. • Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:
	o feel very tired o poor appetite or vomiting	o skin or eyes look yellow o pain on the right side of your stomach (abdomen)
• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with ABRILADA. Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with ABRILADA may be stopped. The most common side effects of ABRILADA include: • injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse. • upper respiratory infections (including sinus infections). • headaches. • rash. These are not all of the possible side effects with ABRILADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ABRILADA? • Store ABRILADA in the refrigerator at 36°F to 46°F (2°C to 8°C). Store ABRILADA in the original carton until use to protect it from light. • Do not freeze ABRILADA. Do not use ABRILADA if frozen, even if it has been thawed. • Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton, pen or prefilled syringe. Do not use ABRILADA after the expiration date. • If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 86°F (30°C) for up to 30 days. Store ABRILADA in the original carton until use to protect it from light. • Throw away ABRILADA if it has been kept at room temperature and not been used within 30 days. • Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton. • Do not store ABRILADA in extreme heat or cold. • The medicine in ABRILADA should be clear and colorless to very light brown. Do not use a pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. • Do not drop or crush ABRILADA. The prefilled syringe is glass. Keep ABRILADA, injection supplies, and all other medicines out of the reach of children.
General information about the safe and effective use of ABRILADA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABRILADA for a condition for which it was not prescribed. Do not give ABRILADA to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ABRILADA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABRILADA that is written for health professionals.
What are the ingredients in ABRILADA? Active ingredient: adalimumab-afzb ABRILADA pen 40 mg/0.8 mL, ABRILADA 40 mg/0.8 mL prefilled syringe, ABRILADA 20 mg/0.4 mL prefilled syringe, ABRILADA 10 mg/0.2 mL prefilled syringe, and ABRILADA 40 mg/0.8 mL institutional use vial: Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and Water for Injection. Manufactured by Pfizer Inc. New York, NY 10001 Distributed by Pfizer Labs Division of Pfizer Inc. New York, NY 10001 US License No. 2001 LAB-1351-6.0 For more information go to www.Pfizer.com.

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