HYRIMOZ 20 mg/.2mL
adalimumab-adaz · INJECTION, SOLUTION · Sandoz Inc
HYRIMOZ is a injection, solution containing adalimumab-adaz at 20 mg/.2mL, taken subcutaneous. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- HYRIMOZ
- Generic Name
- adalimumab-adaz
- NDC Code (Product)
61314-476- Manufacturer
- Sandoz Inc
- Strength
- 20 mg/.2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761071
- Drug Class
- Tumor Necrosis Factor Blocker [EPC]
- Marketing Start
- 07/01/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HYRIMOZ is a tumor necrosis factor (TNF)-blocker indicated for: • 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 rheumatoid arthritis. ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . (1.3) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use : Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer by subcutaneous injection (2) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.2): • Adults: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis or Pediatric Uveitis (2.3): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease (2.4): • Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. • Pediatric Patients 6 Years of Age and Older: Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis (2.5): • Adults : 160 mg on Day 1 (given in one day or split ov…
Contraindications
4 CONTRAINDICATIONS None. None (4)
Drug Interactions
7 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 ) * 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. 7.1 Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent clearance of adalimumab, the data do not suggest the need for dose adjustment of either HYRIMOZ or MTX [see Clinical Pharmacology (12.3) ] . 7.2 Biological Products In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF-blockers with anakin…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Malignancies [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Hepatitis B Virus Reactivation [see Warnings and Precautions (5.4) ] • Neurologic Reactions [see Warnings and Precautions (5.5) ] • Hematological Reactions [see Warnings and Precautions (5.6) ] • Heart Failure [see Warnings and Precautions (5.8) ] • Autoimmunity [see Warnings and Precautions (5.9) ] Most common adverse reactions (>10%) are: 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 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction with ada…
Frequently Asked Questions
What is HYRIMOZ used for?
HYRIMOZ contains adalimumab-adaz. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is HYRIMOZ a controlled substance?
HYRIMOZ is not classified as a controlled substance by the DEA.
What is the generic name for HYRIMOZ?
The generic name for HYRIMOZ is adalimumab-adaz. There are 2 other brand versions of adalimumab-adaz.
What is the NDC code for HYRIMOZ 20 mg/.2mL?
The NDC (National Drug Code) for HYRIMOZ 20 mg/.2mL is 61314-476, listed by Sandoz Inc.