Evenity (2 Syringes) (romosozumab-aqqg)

No dosing information is available for this tab.

Romosozumab is administered by subcutaneous injection by a health-care professional; the drug should not be administered IV or by IM injection.

Romosozumab-aqqg injection is commercially available in single-use prefilled syringes containing 105 mg of the drug in 1.17 mL of solution. A single 210-mg dose of romosozumab-aqqg requires administration of the entire contents of 2 prefilled syringes sequentially at separate injection sites.

Subcutaneous injections of romosozumab should be administered into the abdomen, anterior thigh, or outer aspect of the upper arm; injections within 2 inches of the navel should be avoided. A different injection site should be used each time the drug is administered. If an injection is made at the site of a prior injection, the site of the previous injection should be avoided. Injections should not be made into areas of the skin that are tender, bruised, red, or hard; scars and stretch marks also should be avoided.

Romosozumab-aqqg should be stored at 2-8degreesC in the original carton protected from light. After removal from refrigeration, romosozumab-aqqg may be kept at room temperature for up to 30 days; if not used within that time, the drug should be discarded. Romosozumab-aqqg should not be frozen, exposed to temperatures exceeding 25degreesC, or shaken.

Prior to administration, prefilled syringes of romosozumab-aqqg should sit at room temperature for at least 30 minutes; other methods should not be used to warm the drug. Romosozumab-aqqg should appear clear to opalescent and colorless to light yellow; the solution should not be used if it is cloudy, discolored, or contains particles.

No dosing information is available for this tab.

The risk of pharmacokinetic drug interactions with romosozumab is expected to be low.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

Romosozumab is contraindicated in patients with hypocalcemia (preexisting hypocalcemia must be corrected prior to initiating romosozumab) or a history of systemic hypersensitivity reactions (e.g., angioedema, erythema multiforme, urticaria) to romosozumab or any ingredient in the formulation. (See Hypocalcemia under Warnings/Precautions: Other Warnings and Precautions and also see Sensitivity Reactions under Warnings/Precautions, in Cautions.)

• Acute myocardial infarction
• Cerebrovascular accident
• History of cerebrovascular accident

• Aseptic necrosis of jaw bone
• Atypical femoral fracture
• Hypocalcemia

• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min

Adverse effects reported in clinical trials in 5% or more of patients receiving romosozumab-aqqg include arthralgia and headache.

Rare or Very Rare

• Acute myocardial infarction
• Anaphylaxis
• Angioedema
• Aseptic necrosis of jaw bone
• Atypical femoral fracture
• Cerebrovascular accident
• Erythema multiforme
• Hypocalcemia

More Frequent

• Arthralgia
• Headache disorder

Less Frequent

• General weakness
• Injection site sequelae
• Insomnia
• Muscle spasm
• Neck pain
• Paresthesia
• Peripheral edema
• Skin inflammation
• Skin rash

Rare or Very Rare

• Urticaria

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Safety and efficacy of romosozumab have not been established in pediatric patients.

In animal reproduction studies, skeletal abnormalities (e.g., syndactyly, polydactyly) were observed in the offspring of pregnant rats receiving romosozumab-aqqg during the period of organogenesis at exposure levels of at least 32 times the exposure at the recommended human dosage; minimal to slight decreases in femoral bone mineral density and/or cortical circumference were observed when the drug was administered to female rats beginning prior to mating and continuing through lactation at exposure levels equivalent to 1.5-56 times the exposure at the recommended human dosage.

Romosozumab is not indicated for use in women of childbearing potential.

When romosozumab-aqqg was administered to female rats beginning 6 weeks before cohabitation and continuing through mating and lactation at exposure levels equivalent to 1.5-56 times the exposure at the recommended human dosage, the drug was detected in the serum of rat pups on postnatal day 21 at exposure levels of 0.01-2.4 times maternal exposure; concentrations were dose dependent and resulted from exposure during gestation and/or nursing.

Romosozumab is not indicated for use in women of childbearing potential.

The manufacturer makes no special dosage recommendations for geriatric patients. Most patients in clinical trials of romosozumab-aqqg were 65 years of age or older. (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Of the 6544 postmenopausal women with osteoporosis studied in clinical trials of romosozumab-aqqg, 80% were 65 years of age or older and 37% were 75 years of age or older. Although no overall differences in safety or efficacy were observed between these women and younger women, and other clinical experience revealed no age-related differences in response, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.