For: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis
Hyrimoz (adalimumab-adaz) is an anti-TNF-? monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn�s disease, ulcerative colitis, and plaque psoriasis. HYRIMOZ single-dose pre-filled Sensoready� Pen and HYRIMOZ single-dose pre-filled syringe with BD UltraSafe Passive� Needle Guard and add-on finger flangeHYRIMOZ (adalimumab-adaz) is supplied as a preservative-free, sterile clear, colorless to slightly yellowishsolution for subcutaneous administration. The following packaging configurations are available. Each HYRIMOZ single-dose pre-filled Sensoready�Pen and HYRIMOZ single-dose pre-filled syringe contains 40 mg/0.8 mL of adalimumab in a 1 mL single-dose syringe with a 27-gauge, �-inch needle. The gray needle cover within the needle cap contains natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex. 40 mg/0.8 mL single-dose pre -filled syringewith BD UltraSafe PassiveTM Needle Guard Carton of 2 NDC 61314-876-02 Reference ID: 4342864
�HYRIMOZ single-dose pre- filled syringe � 40 mg/0.8 mL (2 count)HYRIMOZ is supplied in a carton containing 2 blister packages. Each blister package consists of a single-dose, 1 mL pre-filled glass syringe with a fixed 27 gauge, � inch needle, providing 40 mg/0.8 mL of HYRIMOZ. The gray needle cap contains natural rubber. The NDC number is 61314-876-02. �HYRIMOZ single-dose pre- filled Sensoready� Pen � 40 mg/0.8 mL (2 count) HYRIMOZ is supplied in a carton containing 2 single-dose pre-filled Sensoready� Pens. Each Pen consists of a single-dose, 1 mL pre-filled glass syringe with a fixed 27 gauge, � inch needle, providing 40 mg/0.8 mL of HYRIMOZ. The gray needle cover within the needle cap contains natural rubber. The NDC number is 61314-871-02. �HYRIMOZsingle-dose pre-filled Sensoready� Pen � 40 mg/0.8 mL � Starter Pack for Crohn�s Disease or Ulcerative Colitis (6 count)HYRIMOZis supplied in a multipack containing 3x2 packs. Each 2-count pack consists of 2 single-dose pre -filled Sensoready� Pens, containing a 1 mL pre-filled glass syringe with a fixed 27 gauge, � inch needle, providing 40 mg/0.8 mL of HYRIMOZ. The gray needle cap within the needle cover contains natural rubber. The NDC number is 61314-871-06. Storage and Stability Do not use beyond the expiration date on the container. HYRIMOZ must be refrigerated at 36�F to 46�F (2�C to 8�C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light. If needed, for example when traveling, HYRIMOZ may be stored at room temperature up to a maximum of 77�F (25�C) for a period of up to 14 days, with protection from light. HYRIMOZ should be discarded if not used within the 14-day period. Record the date when HYRIMOZ is first removed from the refrigerator in the spaces provided on the carton. Do not store HYRIMOZ in extreme heat or cold. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HYRIMOZTM safely and effectively. See full prescribing information for HYRIMOZ . HYRIMOZ (adalimumab-ad az ) injection, for subcutaneous useInitial U.S. Approval: 2018 HYRIMOZ (adalimumab-ada z) is biosimilar* to HUMIRA (adalimumab)WARNING: SERIOUS INFECTIONS ANDMALIGNANCYSee full prescribing information for complete boxed warning.SERIOUS INFECTIONS(5.1 , 6.1 ): �Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. �Discontinue HYRIMOZ if a patient develops a serious infection or sepsis during treatment. �Perform test for latent TB; if positive, start treatment for TB prior to starting HYRIMOZ. �Monitor all patients for active TB during treatment, even if initial latent TB test is negative.MALIGNANCY (5.2): �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-cel l lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumabproducts.----------------------------INDICATIONS AND USAGE---------------------------HYRIMOZ is a tumor necrosis factor (TNF)-blocker indicated for treatment of: �Rheumatoid Arthritis (RA) (1.1 ): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. �Juvenile Idiopathic Arthritis (JIA) (1.2): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older. �Psoriatic Arthritis (PsA) (1.3): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. �Ankylosing Spondylitis (AS) (1.4): Reducing signs and symptoms in adult patients with active AS. �Adult Crohn�s Disease (CD) (1.5): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn�s Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. �Ulcerative Colitis (UC) (1.7): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HYRIMOZ has not been established in patients who have lost response to or were intolerant to TNF-blockers. �Plaque Psoriasis (Ps) (1.8): The treatment of adult patients with mode rate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ----------------------------DOSAGE AND ADMINISTRATION------------------�Administered by subcutaneous injection (2) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.1): �40 mg every other week. �Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. Juvenile Idiopathic Arthritis (2.2): �? 30 kg (66 lbs): 40 mg every other week Adult Crohn's Disease and Ulcerative Colitis (2.3 , 2.5): �Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)�Second dose two weeks later (Day 15): 80 mg �Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week. �For patients with Ulcerative Colitis only: Only continue HYRIMOZ in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. Plaque Psoriasis (2.6): �80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. ----------------------------DOSAGE FORMS AND STRENGTHS--------------- �Injection: 40 mg/0.8 mL in a single- dose pre -filled glass syringe (with BD UltraSafe Passive� Needle Guard ) (3) �Injection: 40 mg/0.8 mL in a singl e- dose pre -filled pen (Sensoready�Pen ) (3) ----------------------------CONTRAINDICATIONS---------------------------------None (4) ----------------------------WARNINGS AND PRECAUTIONS-------------------�Seri ous infections: Do not start HYRIMOZ during an active infection. If an infection develops, monitor carefully, and stop HYRIMOZ if infection becomes serious (5.1) �Invasive fungal infections: For patients who dev elop a systemic illness on HYRIMOZ, con sider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic (5.1) �Malignancies: Incidence of malignancies was greater in adalimumab -tr eated patients than in controls (5.2) �Anaphylaxis or serious allergic reactionsmay occur (5.3) �Hepatitis B virus reactivation:Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HYRIMOZ and begin ant i- viral therapy (5.4) �Demyelinating disease: Exacerbation or new onset, may occur (5.5) �Cytopenias, pancytopenia:Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HYRIMOZ (5.6) �Heart failure: Worsening or new onset, may occur (5.8) �Lupus -like syndrome: Stop HYRIMOZ if syndrome develops (5.9) ----------------------------ADVERSE REACTIONS---------------------------------Most common adverse reactions (incidence > 10 %): infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800 -525 -8747 or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch----------------------------DRUG INTERACTIONS---------------------------------�Abatacept: Increased risk of serious infection (5.1, 5.11, 7.2) �Anakinra: Increased risk of serious infection (5.1, 5.7, 7.2) �Live vaccines: Avoid use with HYRIMOZ (5.10, 7.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide* Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of HYRIMOZ has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.Revised: 10 /2018
