Praluent Pen (alirocumab)

No dosing information is available for this tab.

Administer alirocumab by subcutaneous injection.

Train patients and/or their caregivers on how to prepare and administer alirocumab using the prefilled injection pen provided by the manufacturer. Alirocumab should be administered by or under the supervision of an adult in children 12 to 17 years of age; it should be administered by a caregiver in children 8 to 11 years of age.

Prior to use, the prefilled pens should be stored at 2-8degreesC in their original carton to protect from light; the drug should not be frozen, shaken, or exposed to extreme heat or direct sunlight. Prior to administration, alirocumab should be allowed to warm to room temperature for 30-40 minutes; the drug should not be returned to the refrigerator after removal and should be used within 30 days or discarded.

Alirocumab injection is a clear, colorless to pale yellow solution. The solution should be inspected visually prior to administration and should not be used if discolored, cloudy, or contains any particles. Commercially available alirocumab injection contains no preservatives and is intended for single use only.

Subcutaneous injections of alirocumab should be administered into areas of the thigh, abdomen (except for the 2-inch area around the navel), or upper arm that are not tender, bruised, red, or indurated; injection sites should be rotated. Injection of alirocumab may take up to 20 seconds to complete.

To administer a 300-mg dose of alirocumab, administer 2 consecutive doses of 150 mg at 2 different injection sites.

If a dose of alirocumab is missed, the dose should be administered as soon as possible within 7 days. If a missed dose is not administered within 7 days in a patient receiving the every-2-week regimen, the dose should be withheld and the next dose should be administered at the regularly scheduled time. If a missed dose is not administered within 7 days in a patient receiving the once-monthly regimen, the dose should be administered and a new dosing schedule should be initiated starting on that date.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

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)

*History of serious hypersensitivity reaction to alirocumab or any of its excipients.

There are no contraindication contraindications for this drug.

• Pregnancy

There are no moderate contraindications for this drug.

Adverse effects reported in >5% of patients receiving alirocumab and more frequently than placebo in primary hyperlipidemia studies include injection site reactions and influenza.

Adverse effects reported in >5% of patients receiving alirocumab and more frequently than placebo in patients with established cardiovascular disease include myalgia.

Less Frequent

• Abnormal hepatic function tests
• Hypersensitivity drug reaction

Rare or Very Rare

• Angioedema
• Hypersensitivity angiitis

More Frequent

• Influenza
• Injection site sequelae
• Pharyngitis

Less Frequent

• Bronchitis
• Bruising
• Cough
• Diarrhea
• Muscle spasm
• Musculoskeletal pain
• Myalgia
• Pruritus of skin
• Sinusitis
• Skin rash
• Urinary tract infection

Rare or Very Rare

• Acute cognitive impairment
• Eczema
• Flu-like symptoms
• Memory impairment
• Urticaria

No enhanced messaging available.

Safety and efficacy of alirocumab as an adjunct to diet and other LDL-lowering therapies for the treatment of HeFH were established in pediatric patients >=8 years of age based on data from a 24-week, randomized, placebo-controlled, double-blind trial involving 153 pediatric patients with HeFH and evidence from controlled trials in adults.

Available data from clinical trials and post-marketing reports are insufficient to determine the drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes of alirocumab use during pregnancy. Monoclonal antibodies cross the placenta in increasing amounts closer to term; therefore, placental transfer of alirocumab can occur from the mother to the developing fetus.

In animal reproductive studies, no adverse embryofetal effects were observed in rats exposed to alirocumab during the period of organogenesis; however, in utero exposure to the drug appeared to suppress the humoral immune response in infant monkeys. Alirocumab was administered at dose exposures of 12-13 times the maximum recommended human dosage in these animal studies.

To monitor pregnancy outcomes in pregnant women exposed to alirocumab, a pregnancy safety study is being conducted. Clinicians and patients should call 1-844-734-6643 to report alirocumab exposure during pregnancy.

It is not known whether alirocumab is distributed into human milk; the effects of alirocumab on the breastfed infant or on milk production are also unknown. Human IgG is distributed into human milk; however, published data suggest that IgG antibodies present in human milk are not substantially distributed into the circulation of neonates and infants. The potential adverse effects of alirocumab on the infant should be weighed against the known benefits of breastfeeding, taking into account the importance of the drug to the woman.

No specific dosage recommendations in geriatric patients.

Controlled studies involving alirocumab included 3663 patients >=65 years of age and 734 patients >=75 years of age. Although no overall differences in safety or efficacy have been observed between geriatric patients and younger adults in controlled studies or in other clinical experience, the possibility of increased sensitivity to alirocumab in some geriatric patients cannot be ruled out.