Adakveo (crizanlizumab-tmca)

No dosing information is available for this tab.

Crizanlizumab-tmca is available as a 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.

If a dose is missed, administer crizanlizumab-tmca as soon as possible.

If crizanlizumab-tmca is administered within 2 weeks after the missed dose, continue dosing according to the patient's original schedule.

If crizanlizumab-tmca is administered >2 weeks after the missed dose, continue dosing every 4 weeks thereafter.

Crizanlizumab-tmca should be prepared and administered by a health care professional as an IV infusion. Whenever container and solution permit, visually inspect product for particulate matter or discoloration prior to administration. Do not use if particles are present in solution. Solution should be clear to opalescent, colorless or with a slightly brownish-yellow tint. Store unopened vials under refrigeration at 2-8degreesC in the original carton to protect from light. Do not shake or freeze.

Calculate the dose (mg) and the total volume (mL) of crizanlizumab-tmca solution required and the number of vials needed based on the patient's actual body weight. Calculate the volume of crizanlizumab-tmca to be used using the following equation:

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Disease Modifying Agents/Exagamglogene Autotemcel

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The interaction potential of disease modifying agents with exagamglogene autotemcel is unknown.(1)

CLINICAL EFFECTS: Disease modifying agents may interfere with exagamglogene autotemcel therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Discontinue disease modifying therapies for sickle cell disease (e.g. voxelotor, crizanlizumab) at least 8 weeks prior to the start of mobilization.(1) It is recommended that patients be transfused at least 8 weeks prior to the initiation of myeloablative conditioning. At initiation of red blood cell exchange or simple transfusions, discontinue disease modifying therapies for sickle cell disease (e.g. voxelotor, crizanlizumab).(1)

DISCUSSION: There is no experience with the use of disease modifying agents with exagamglogene autotemcel infusion.(1)

Disease Modifying Agents/Lovotibeglogene Autotemcel

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The interaction potential of disease modifying agents with lovotibeglogene autotemcel is unknown.(1)

CLINICAL EFFECTS: Disease modifying agents may interfere with lovotibeglogene autotemcel therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Discontinue disease modifying therapies (e.g. voxelotor, crizanlizumab) for sickle cell disease at least 8 weeks prior to start of mobilization and conditioning.(1)

DISCUSSION: There is no experience with the use of disease modifying agents with lovotibeglogene autotemcel infusion.(1)

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)

None.

There are no contraindication contraindications for this drug.

• Pregnancy

There are no moderate contraindications for this drug.

Most common adverse reactions (incidence >10%) are nausea, arthralgia, back pain, abdominal pain, and pyrexia.

There are no severe adverse reactions for this drug.

More Frequent

• Arthralgia
• Back pain
• Fever
• Nausea

Less Frequent

• Acute abdominal pain
• Chills
• Diarrhea
• Dizziness
• Dyspnea
• Fatigue
• Hyperhidrosis
• Injection site sequelae
• Myalgia
• Non-cardiac chest pain
• Pain in oropharynx
• Pruritus of skin
• Urticaria
• Vomiting
• Vulvovaginitis
• Wheezing

No enhanced messaging available.

The safety and effectiveness of crizanlizumab-tmca for sickle cell disease have been established in pediatric patients >=16 years of age. Use of crizanlizumab-tmca for sickle cell disease is supported by evidence from adequate and well-controlled studies in adults and pediatric patients >=16 years of age (SUSTAIN trial). The SUSTAIN trial enrolled 1 pediatric patient, 16 years of age, treated with crizanlizumab-tmca 5 mg/kg.

Safety and efficacy of crizanlizumab-tmca in pediatric patients <16 years of age have not been established.

Based on data from animal studies, crizanlizumab-tmca has the potential to cause fetal harm when administered to a pregnant woman. In an animal reproduction study, IV administration of crizanlizumab-tmca to pregnant cynomolgus monkeys from the onset of organogenesis through delivery resulted in a non-dose related increase in fetal loss (abortions/stillbirths) at doses approximately 2.8 times the exposure at the recommended clinical dosage (5 mg/kg/dose once every 4 weeks).

There are insufficient human data on crizanlizumab-tmca use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus. Pregnant women are at greater risk for vasoocclusive crises, pre-eclampsia, eclampsia, and maternal mortality. For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality. Advise pregnant women of the potential risk of crizanlizumab-tmca to a fetus. Crizanlizumab-tmca should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

There are no data on the presence of crizanlizumab-tmca in human or animal milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local GI exposure and limited systemic exposure in the breastfed child to crizanlizumab-tmca are unknown.

Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for crizanlizumab-tmca and any potential adverse effects on the breastfed child from crizanlizumab-tmca or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of crizanlizumab-tmca did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger patients.