Brand Name
Cyltezo
Generic Name
Adalimumab-adbm
View Brand Information FDA approval date: July 01, 2023
Form: Kit
What is Cyltezo (Adalimumab-adbm)?
CYLTEZO is a tumor necrosis factor 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.
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Brand Information
Cyltezo (adalimumab-adbm)
1DOSAGE FORMS AND STRENGTHS
CYLTEZO is a clear to slightly opalescent and colorless to slightly yellow solution available as:
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections
- Malignancies
- Hypersensitivity Reactions
- Hepatitis B Virus Reactivation
- Neurologic Reactions
- Hematological Reactions
- Heart Failure
- Autoimmunity
3.1Clinical 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 adalimumab was injection site reactions. In placebo-controlled trials, 20% of subjects treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of subjects receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.
The proportion of subjects who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in subjects with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for subjects taking adalimumab and 4% for placebo-treated subjects. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).
3.2Immunogenicity
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of adalimumab or of other adalimumab products.
There are two assays that have been used to measure anti-adalimumab antibodies. With the ELISA, antibodies to adalimumab could be detected only when serum adalimumab concentrations were <2 mcg/mL. The ECL assay can detect anti-adalimumab antibody titers independent of adalimumab concentrations in the serum samples. The incidence of anti-adalimumab antibody (AAA) development in patients treated with adalimumab are presented in
3.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of adalimumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to adalimumab products exposure.
Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
General disorders and administration site conditions: Pyrexia
Hepato-biliary disorders: Liver failure, hepatitis, autoimmune hepatitis
Immune system disorders: Sarcoidosis
Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia, lichenoid skin reaction
Vascular disorders: Systemic vasculitis, deep vein thrombosis
4OVERDOSAGE
Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Consider contacting the Poison Help line (1-800-222-1222) or medical toxicologist for additional overdose management recommendations.
5DESCRIPTION
Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
CYLTEZO (adalimumab-adbm) injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (CYLTEZO Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of CYLTEZO is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5.
Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP.
Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP.
Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP.
Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of CYLTEZO contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.
6REFERENCES
- National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 17 Registries, 2000-2007.
7HOW SUPPLIED/STORAGE AND HANDLING
CYLTEZO
8PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
9INSTRUCTIONS FOR USE CYLTEZO®(sil-TEE-zoh) Pen (adalimumab-adbm) injection, for subcutaneous use
The CYLTEZO Pen is a single-dose prefilled pen that delivers a fixed dose of medicine. The CYLTEZO Pen cannot be reused.
Important: Read these instructions before using a CYLTEZO Pen.
- Do not use a CYLTEZO Pen until you have been shown the right way to give the injections and have read and understood this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of CYLTEZO at home, you should receive training on the right way to prepare and inject CYLTEZO. To help you remember when to inject CYLTEZO, you can mark your calendar ahead of time.
- Do not remove the cap until you are ready to inject.
How should I store CYLTEZO?
- Store CYLTEZO in the refrigerator at 36°F to 46°F (2°C to 8°C). Store CYLTEZO in the original carton until use to protect it from light.
- Do not freeze CYLTEZO. Do not use CYLTEZO if frozen, even if it has been thawed.
- Refrigerated CYLTEZO may be used until the expiration date printed on the CYLTEZO carton, dose tray, or pen. Do not use CYLTEZO after the expiration date.
- If needed, for example, when you are traveling, you may also store CYLTEZO at room temperature up to 77°F (25°C) for up to 14 days. Store CYLTEZO in the original carton until use to protect it from light.
- Throw away CYLTEZO if it has been kept at room temperature and not been used within 14 days.
- Record the date you first remove CYLTEZO from the refrigerator in the spaces provided on the carton and dose tray.
- Do not store CYLTEZO in extreme heat or cold.
- Do not use a CYLTEZO Pen if the liquid is milky, discolored, or has flakes or particles in it.
- Do not drop or crush CYLTEZO. The prefilled syringe inside the pen is glass.
Keep CYLTEZO, injection supplies, and all other medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
US License Number 2006
CYLTEZO
Other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.
For more information about CYLTEZO, including Prescribing Information and Medication Guide, go to
Copyright © 2024 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
10INSTRUCTIONS FOR USE CYLTEZO®(sil-TEE-zoh) (adalimumab-adbm) injection, for subcutaneous use
Single-Dose CYLTEZO Prefilled Syringe
CYLTEZO is a single-dose prefilled syringe that delivers a fixed dose of medicine. The prefilled syringe cannot be reused.
Important: Read these instructions before using a CYLTEZO prefilled syringe.
- Do not use a CYLTEZO prefilled syringe until you have been shown the right way to give the injections and have read and understood this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections at home, you should receive training on the right way to prepare and give the injection. To help you remember when to inject CYLTEZO, you can mark your calendar ahead of time.
- Do not remove the cap until you are ready to inject.
How should I store CYLTEZO?
- Store CYLTEZO in the refrigerator at 36°F to 46°F (2°C to 8°C). Store CYLTEZO in the original carton until use to protect it from light.
- Do not freeze CYLTEZO. Do not use CYLTEZO if frozen, even if it has been thawed.
- Refrigerated CYLTEZO may be used until the expiration date printed on the CYLTEZO carton, dose tray, or prefilled syringe. Do not use CYLTEZO after the expiration date.
- If needed, for example, when you are traveling, you may also store CYLTEZO at room temperature up to 77°F (25°C) for up to 14 days. Store CYLTEZO in the original carton until use to protect it from light.
- Throw away CYLTEZO if it has been kept at room temperature and not been used within 14 days.
- Record the date you first remove CYLTEZO from the refrigerator in the spaces provided on the carton and dose tray.
- Do not store CYLTEZO in extreme heat or cold.
- Do not use a prefilled syringe if the liquid is milky, discolored, or has flakes or particles in it.
- Do not drop or crush CYLTEZO. The prefilled syringe is glass.
Keep CYLTEZO, injection supplies, and all other medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
US License Number 2006
CYLTEZO
Other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.
For more information about CYLTEZO, including Prescribing Information and Medication Guide, go to
Copyright © 2024 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
11PRINCIPAL DISPLAY PANEL - Kit Carton - 0597-0370-82
NDC 0597-0370-82
CYLTEZO
40 mg/0.8 mL
For Subcutaneous Use Only
Rx only
2 Single-Dose Prefilled Syringes
ATTENTION PHARMACIST:
The Entire Carton is to be Dispensed as a Unit.
Needle Cap for Syringe Contains Dry Natural Rubber.
Boehringer
12PRINCIPAL DISPLAY PANEL - Kit Carton - 0597-0405-80
NDC 0597-0405-80
CYLTEZO
20 mg/0.4 mL
For Subcutaneous Use Only
Rx only
2 Single-Dose Prefilled Syringes
ATTENTION PHARMACIST:
The Entire Carton is to be Dispensed as a Unit.
Needle Cap for Syringe Contains Dry Natural Rubber.
Boehringer
13PRINCIPAL DISPLAY PANEL - Kit Carton - 0597-0400-89
NDC 0597-0400-89
CYLTEZO
10 mg/0.2 mL
For Subcutaneous Use Only
Rx only
2 Single-Dose Prefilled Syringes
ATTENTION PHARMACIST:
The Entire Carton is to be Dispensed as a Unit.
Needle Cap for Syringe Contains Dry Natural Rubber.
Boehringer
14PRINCIPAL DISPLAY PANEL - Kit Carton - 0597-0375-97
NDC 0597-0375-97
CYLTEZO
40 mg/0.8 mL
For Subcutaneous Use Only
Rx only
2 Single-Dose Prefilled Pens
ATTENTION PHARMACIST:
The Entire Carton is to be Dispensed as a Unit.
Needle Cap for Pen Contains Dry Natural Rubber.
Boehringer
15PRINCIPAL DISPLAY PANEL - Kit Carton - 0597-0485-20
NDC 0597-0485-20
CYLTEZO
40 mg/0.4 mL
For Subcutaneous Use Only
Rx only
2 Single-Dose Prefilled Syringes
ATTENTION PHARMACIST:
The Entire Carton is to be Dispensed as a Unit.
Needle Cap for Syringe Contains Dry Natural Rubber.
Boehringer
16PRINCIPAL DISPLAY PANEL - Kit Carton - 0597-0495-50
NDC 0597-0495-50
CYLTEZO
40 mg/0.4 mL
For Subcutaneous Use Only
Rx only
2 Single-Dose Prefilled Pens
ATTENTION PHARMACIST:
The Entire Carton is to be Dispensed as a Unit.
Needle Cap for Pen Contains Dry Natural Rubber.
Boehringer
