RITUXAN Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Genentech, Inc.

Λέξεις κλειδιά

50242-051 50242-053

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BOXED WARNING SECTION

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions RITUXAN ...

1. Indications and Usage

1.1 Non–Hodgkins Lymphoma (NHL) RITUXAN (rituximab) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. ...

2. Dosage and Administration

2.1 Important Dosing Information Administer only as an Intravenous Infusion [see Dosage and Administration (2.8)]. Do not administer as an intravenous push or bolus. RITUXAN should only ...

3. Dosage Forms and Strengths

Injection: RITUXAN is a colorless, clear solution for intravenous infusion: 100 mg/10 mL (10 mg/mL) in a single-dose vial 500 mg/50 mL (10 mg/mL) in a single-dose vial

4. Contraindications

None.

5. Warnings and Precautions

5.1 Infusion-Related Reactions RITUXAN can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30–120 minutes. ...

6. Adverse Reactions

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infusion-related reactions [see Warnings and Precautions (5.1)] Severe ...

6.1. Clinical Trials Experience

6.1 Clinical Trials Experience in Lymphoid Malignancies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be ...

6.5. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

6.6. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of RITUXAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Formal drug interaction studies have not been performed with RITUXAN. In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with ...

8.1. Pregnancy

Risk Summary Based on human data, RITUXAN can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to RITUXAN in-utero (see Clinical Considerations). In animal ...

8.2. Lactation

There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. However, rituximab is detected in the milk of lactating cynomolgus monkeys, ...

8.3. Females and Males of Reproductive Potential

Contraception RITUXAN can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Females Advise females of reproductive potential to use effective contraception ...

8.4. Pediatric Use

RITUXAN is indicated for the treatment of GPA and MPA in pediatric patients 2 years of age and older with GPA and MPA. RITUXAN is not indicated in pediatric patients less than 2 years of age with GPA or ...

8.5. Geriatric Use

Diffuse Large B-Cell NHL Among patients with DLBCL evaluated in three randomized, active-controlled trials, 927 patients received RITUXAN in combination with chemotherapy. Of these, 396 (43%) were age ...

11. Description

Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituximab ...

12.1. Mechanism of Action

Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis. Possible mechanisms of ...

12.2. Pharmacodynamics

Non-Hodgkins Lymphoma (NHL) In NHL patients, administration of RITUXAN resulted in depletion of circulating and tissue-based B cells. Among 166 patients in NHL Study 1 (NCT000168740), circulating CD19-positive ...

12.3. Pharmacokinetics

Non-Hodgkins Lymphoma (NHL) Pharmacokinetics were characterized in 203 NHL patients receiving 375 mg/m² RITUXAN weekly by intravenous infusion for 4 doses. Rituximab was detectable in the serum of patients ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to establish the carcinogenic or mutagenic potential of RITUXAN or to determine potential effects on fertility in males or females.

14. Clinical Studies

14.1 Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL The safety and effectiveness of RITUXAN in relapsed, refractory CD20+ NHL were demonstrated in 3 single-arm studies enrolling ...

16.1. How Supplied

RITUXAN (rituximab) injection is a sterile, preservative-free, clear, colorless solution for intravenous infusion supplied as follows: Carton contents NDC number One 100 mg/10 mL (10 mg/mL) single-dose ...

16.2. Storage and Handling

Store RITUXAN vials refrigerated at 2°C to 8°C (36°F to 46°F). RITUXAN vials should be protected from direct sunlight. Do not freeze or shake.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infusion-Related Reactions Inform patients about the signs and symptoms of infusion-related reactions. Advise patients to ...