EVENITY Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Amgen Inc
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1. Indications and Usage
1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a ...
2. Dosage and Administration
2.1 Important Dosage and Administration Instructions Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 ...
3. Dosage Forms and Strengths
Injection: 105 mg/1.17 mL clear to opalescent, colorless to light yellow solution in a single-use prefilled syringe. A full dose of EVENITY requires two single-use prefilled syringes.
4. Contraindications
EVENITY is contraindicated in patients with: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY <em>[see Warnings and Precautions (5.3), Adverse Reactions ...
5. Warnings and Precautions
5.1 Major Adverse Cardiac Events (MACE) In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular ...
6. Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events <em>[see Boxed Warning and Warnings and Precautions (5.1)]</em> Hypersensitivity ...
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 ...
6.2. Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...
8.1. Pregnancy
Risk Summary EVENITY is not indicated for use in women of reproductive potential. In animal reproduction studies, weekly administration of romosozumab-aqqg to pregnant rats during the period of organogenesis ...
8.2. Lactation
Risk Summary EVENITY is not indicated for use in women of reproductive potential. In animal studies where pregnant rats were given weekly doses of romosozumab-aqqg from 6 weeks before cohabitation through ...
8.4. Pediatric Use
Safety and effectiveness of EVENITY have not been established in pediatric patients.
8.5. Geriatric Use
Of the 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over. No overall differences in safety ...
8.7. Renal Impairment
No dose adjustment is required in patients with renal impairment. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m² by MDRD equation) or receiving ...
11. Description
Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg ...
12.1. Mechanism of Action
EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg ...
12.2. Pharmacodynamics
In postmenopausal women with osteoporosis, EVENITY increased the bone formation marker procollagen type 1 N-telopeptide (P1NP) with a peak increase from baseline of approximately 145% compared to placebo ...
12.3. Pharmacokinetics
Administration of a single dose of 210 mg EVENITY in healthy volunteers resulted in a mean (standard deviation [SD]) maximum romosozumab-aqqg serum concentration (C<sub>max</sub>) of 22.2 (5.8) mcg/mL ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity In a rat carcinogenicity study, once-weekly romosozumab-aqqg doses of 3, 10 or 50 mg/kg were administered by subcutaneous injection to Sprague-Dawley rats from 8 weeks up to 98 weeks of ...
13.2. Animal Toxicology and/or Pharmacology
No adverse effects were noted in rats and monkeys after 26 once-weekly subcutaneous romosozumab-aqqg doses up to 100 mg/kg, equivalent to systemic exposures of 37 and 90 times, respectively, the systemic ...
14. Clinical Studies
14.1 Treatment of Osteoporosis in Postmenopausal Women <b>Study 1</b> (NCT01575834) was a randomized, double-blind, placebo-controlled study of postmenopausal women aged 55 to 90 years (mean age of 71 ...
16.1. How Supplied
EVENITY (romosozumab-aqqg) injection is a clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-use prefilled syringe. Each single-use prefilled syringe ...
16.2. Storage and Handling
Refrigerate EVENITY at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. If removed from the refrigerator, EVENITY can be kept at room temperature up ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Major Adverse Cardiac Events Advise patients to seek immediate medical attention if they experience signs or symptoms of ...
BOXED WARNING SECTION
<b>WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH</b> <b>EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death <em>[see Warnings and ...