EVENITY- romosozumab-aqqg injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ROMOSOZUMAB (UNII: 3VHF2ZD92J) (ROMOSOZUMAB - UNII:3VHF2ZD92J)

Available from:

Amgen Inc

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.  The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.1 )] . EVENITY is contraindicated in patients with: - Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY [ see Warnings and Precautions ( 5.3 ) , Adverse Reactions ( 6.1 ) and Use in Specific Populations ( 8.7 )] . - A history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema m

Product summary:

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 contains 105 mg of EVENITY in a deliverable volume of 1.17 mL. To deliver a full dose, inject two 105 mg/1.17 mL EVENITY prefilled syringes, one after the other for a total dose of 210 mg. The prefilled syringe is not made with natural rubber latex.  

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Amgen Inc
----------
MEDICATION GUIDE
EVENITY® (E-ven-i-tee)
(romosozumab-aqqg)
Injection, for subcutaneous use
What is the most important information I should know about EVENITY?
EVENITY can cause serious side effects, including:
•
increased risk of having a heart attack, stroke, or death from a
cardiovascular (heart or blood vessel) problem. Call your healthcare
provider or get emergency help right away if you have any of the
symptoms listed below.
•
Symptoms of heart attack may include:
•
chest pain or pressure
•
shortness of breath
•
feeling light-headed or dizzy
•
Symptoms of stroke may include:
•
headache
•
numbness or weakness in face, arm, or legs
•
difficulty talking
•
changes in vision or loss of balance
Before you receive EVENITY, tell your healthcare provider if you have
had a
heart attack or stroke, especially if it has happened in the past
year.
See “What are the possible side effects of EVENITY?” below for
other side
effects of EVENITY.
What is EVENITY?
EVENITY is a prescription medicine used to:
•
treat osteoporosis (thinning and weakening of bone) in women after
menopause (“change of life”) who:
•
are at high risk of fracture (broken bone), or
•
cannot use another osteoporosis medicine or other osteoporosis
medicines did not work well.
It is not known if EVENITY is safe and effective in children.
Do not receive EVENITY if you:
•
have been told by your healthcare provider that your blood calcium
level is too low.
•
are allergic to romosozumab or any of the ingredients in EVENITY.
See the end of this Medication Guide for a complete list of
ingredients
in EVENITY.
Before receiving EVENITY, tell your healthcare provider about all your
medical conditions, including if you:
•
have a history of other heart or blood vessel problems
•
have low blood calcium
•
cannot take daily calcium and vitamin D
•
have kidney problems or are on kidney dialysis
•
plan to have dental surgery or teeth removed
Tell your healthcare provider about all the medicines you take,
i

Summary of Product characteristics

EVENITY- ROMOSOZUMAB-AQQG INJECTION, SOLUTION
AMGEN INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVENITY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVENITY.
EVENITY (ROMOSOZUMAB-AQQG) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2019
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND
CARDIOVASCULAR DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• EVENITY MAY INCREASE THE RISK OF MYOCARDIAL INFARCTION, STROKE AND
CARDIOVASCULAR
DEATH. (5.1)
• EVENITY SHOULD NOT BE INITIATED IN PATIENTS WHO HAVE HAD A
MYOCARDIAL INFARCTION OR
STROKE WITHIN THE PRECEDING YEAR. CONSIDER WHETHER THE BENEFITS
OUTWEIGH THE RISKS IN
PATIENTS WITH OTHER CARDIOVASCULAR RISK FACTORS. (5.1)
• IF A PATIENT EXPERIENCES A MYOCARDIAL INFARCTION OR STROKE DURING
THERAPY, EVENITY
SHOULD BE DISCONTINUED. (5.1)
INDICATIONS AND USAGE
EVENITY is a sclerostin inhibitor indicated for the treatment of
osteoporosis in postmenopausal women at
high risk for fracture, defined as a history of osteoporotic fracture,
or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available
osteoporosis therapy. (1)
Limitations of Use: Limit duration of use to 12 monthly doses. If
osteoporosis therapy remains warranted,
continued therapy with an anti-resorptive agent should be considered.
(1.2)
DOSAGE AND ADMINISTRATION
Two separate subcutaneous injections are needed to administer the
total dose of 210 mg. Inject two
syringes, one after the other. (2.1)
Should be administered by a healthcare provider. (2.1)
Administer 210 mg subcutaneously once every month for 12 doses in the
abdomen, thigh, or upper
arm. (2.2)
Adequately supplement calcium and vitamin D during treatment. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 105 mg/1.17 mL solution in a single-use prefilled syringe.
A full dose of EVENITY requires two
single-use prefilled syringes. (3)
CONTRAINDICATIONS
Hypocalcemia (4)
Known hypersensiti