Romosozumab
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (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. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. 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 )
Dosing in kidney impairment
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 m 2 by MDRD equation) or receiving dialysis are at greater risk of developing hypocalcemia [see Contraindications , Warnings and Precautions and Adverse Reactions ] .
Monitor calcium concentrations and adequately supplement calcium and vitamin D in patients who have severe renal impairment or are receiving dialysis.
Preparation and administration
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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 mL prefilled syringes, one after the other. EVENITY should be administered by a healthcare provider.
Preparation and Administration Instructions Administration instructions: Prefilled syringe with automatic needle guard: Step 1: Prior to Administration: Remove two syringes from the carton. Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is a clear to opalescent, colorless to light yellow solution.
Do not use if the solution is cloudy or discolored or contains particles. Do not use the syringe if any part appears cracked or broken the gray needle cap is missing or not securely attached the expiration date printed on the label has passed the syringe has been dropped on a hard surface Always hold the syringe by the syringe body to remove the syringe from the tray.
See Figure A . Do not grasp the plunger rod. Do not grasp the gray needle cap. Do not remove the gray needle cap until you are ready to inject. Allow EVENITY to sit at room temperature for at least 30 minutes before injecting. Do not warm in any other way [see How Supplied/Storage and Handling ] . Figure A Step 2: Select the Injection Site and Prepare the Syringe Prepare and clean two injection sites, one for each of the two injections.
See Figure B . Figure B The recommended subcutaneous injection sites include: The thigh Abdomen, except for a two-inch area right around the navel Outer area of upper arm Clean the injection sites with alcohol wipes. Let the skin dry. Choose a different site each time you give an injection. If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. Choose the first syringe. Pull the gray needle cap straight off and away from your body when you are ready to inject. See Figure C . Figure C Do not put the gray needle cap back onto the syringe.
Do not leave the cap off for more than 5 minutes as this can dry out the solution. The prefilled syringe may contain air bubbles. Do not try to push air bubbles out as it is normal to see air bubbles. Step 3: Inject EVENITY Pinch the skin around the injection site before injecting. Insert the needle into the pinched skin at or about a 45-degree angle.
Slowly press the plunger head all the way down with your thumb until it is completely between the needle guard clips. Do not pull back on the plunger rod at any time. Do not remove the syringe until all the medicine has been injected. Do not administer into muscle or blood vessel. See Figure D . Figure D Slowly release pressure on the plunger head with your thumb and remove the syringe from the skin.
Let go of the skin after the needle is removed. Releasing the plunger head covers the used needle. See Figure E . Figure E Step 4: Syringe and Gray Needle Cap Disposal Immediately dispose of the syringe and needle cap in the nearest sharps container. Important: Repeat all steps with the second syringe to inject the full dose.
Figure A Figure B Figure C Figure D Figure E Administration instructions: Prefilled syringe : Step 1: Prior to Administration: Remove two syringes from the carton. Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is a clear to opalescent, colorless to light yellow solution. Do not use if the solution is cloudy or discolored or contains particles.
Do not use the syringe if any part appears cracked or broken the gray needle cap is missing or not securely attached the expiration date printed on the label has passed the syringe has been dropped on a hard surface Always hold the prefilled syringe by the syringe barrel to remove the syringe from the tray. See Figure F .
Do not grasp the plunger rod. Do not grasp the gray needle cap. Do not remove the gray needle cap until you are ready to inject. Allow EVENITY to sit at room temperature for at least 30 minutes before injecting. Do not warm in any other way [see How Supplied/Storage and Handling ] . Figure F Step 2: Select the Injection Site and Prepare the Syringe Prepare and clean two injection sites, one for each of the two injections.
See Figure G . Figure G The recommended subcutaneous injection sites include: The thigh Abdomen, except for a two-inch area right around the navel Outer area of upper arm Clean the injection sites with alcohol wipes. Let the skin dry. Choose a different site each time you give an injection. If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. Choose the first syringe. Pull the gray needle cap straight off and away from your body when you are ready to inject. See Figure H . Figure H Do not put the gray needle cap back onto the syringe.
Do not leave the cap off for more than 5 minutes as this can dry out the solution. The prefilled syringe may contain air bubbles. Do not try to push air bubbles out as it is normal to see air bubbles. Step 3: Inject EVENITY Pinch the skin around the injection site before injecting. Insert the needle into the pinched skin at or about a 45-degree angle.
Insert needle and inject all the liquid subcutaneously. Do not administer into muscle or blood vessel. See Figure I . Figure I When done, gently lift the syringe off of the skin. Step 4: Syringe and Needle Cap Disposal Immediately dispose of the syringe and needle cap in the nearest sharps container. Important: Repeat all steps with the second syringe to inject the full dose.
Figure A Figure B Figure C Figure D
Contraindications
4 CONTRAINDICATIONS 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-aqqg or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Hypocalcemia ( 4 ) Known hypersensitivity to EVENITY ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent acute liver injury.
Romosozumab is a humanized monoclonal antibody to sclerostin which is used to treat osteoporosis. Romosozumab is generally well tolerated and has not been associated with serum aminotransferase elevations during therapy or with instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
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 at exposures greater than 31 times the clinical exposure produced skeletal abnormalities in the offspring. Administration of romosozumab-aqqg to rats prior to mating and through to the end of lactation produced minimal to slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.4 to 54 times the expected exposure in humans [see Data ] .
Data Animal Data Reproductive and developmental effects of romosozumab-aqqg were assessed in the rat in a preliminary and definitive embryo-fetal development study, a combined fertility and embryo-development study, and a pre and postnatal development study. Skeletal malformations including syndactyly and polydactyly occurred in 1 out of 75 litters across all rat reproductive toxicity studies, in the litter of a dam given weekly subcutaneous romosozumab-aqqg doses of 300 mg/kg (equivalent to at least 31 times the clinical exposure observed in humans following a monthly subcutaneous dose of 210 mg, based on area under the concentration-time curve [AUC] comparison).
In the offspring of female rats given weekly romosozumab-aqqg doses from 6 weeks before cohabitation through mating and lactation, femoral periosteal and endocortical circumferences were slightly decreased at 10, 60, and 300 mg/kg (equivalent to 1.4, 18, and 54 times the clinical exposure following a monthly subcutaneous dose of 210 mg, based on AUC comparison). Cortical thickness was increased at 300 mg/kg (equivalent to 54 times expected clinical exposure). Femoral metaphyseal bone mineral density was slightly decreased at 60 and 300 mg/kg (equivalent to 18 and 54 times expected clinical exposure).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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