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CARVYKTI (ciltacabtagene autoleucel)
- multiple myeloma
0.5x 10exp6 to 1x 10exp8 cell intravenous suspension
- Dosage information is not available
- natalizumab
- Tysabri
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Anemia
- Guillain-barre syndrome
- Neutropenic disorder
- Parkinsonism
- Peripheral neuropathy
- Pregnancy
- Severe infection
- Thrombocytopenic disorder
Severe
Moderate
- None
CARVYKTI (ciltacabtagene autoleucel)
- multiple myeloma
- Abnormal hepatic function tests
- Anemia
- Cytokine release syndrome
- Encephalopathy
- Hypoalbuminemia
- Hypogammaglobulinemia
- Hypotension
- Infection
- Lymphopenia
- Neutropenic disorder
- Thrombocytopenic disorder
- Viral infection
- Anorexia
- Chills
- Constipation
- Cough
- Diarrhea
- Dizziness
- Dyspnea
- Edema
- Fatigue
- Fever
- Headache disorder
- Musculoskeletal pain
- Nausea
- Tachycardia
- Upper respiratory infection
- Vomiting
More Frequent
Severe
Less Severe
- Cardiac arrhythmia
- Cranial nerve disorder
- Hemorrhage
- Hypersensitivity drug reaction
- Pneumonia
- Renal failure
- Sepsis
- Thrombotic disorder
- Tumor lysis syndrome
- Accidental fall
- Aphasia
- Bradykinesia
- Chest pain
- Delirium
- Depression
- Dysphagia
- Insomnia
- Peripheral motor neuropathy
- Peripheral sensory neuropathy
- Skin rash
- Urinary tract infection
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Cerebrovascular accident
- Guillain-barre syndrome
- Hemophagocytic lymphohistiocytosis
- Parkinsonism
- Seizure disorder
Less Severe
- Nystagmus
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Ciltacabtagene autoleucel
Safety and effectiveness not established in pediatric patients.
- 1 Day – 18 Years
- Safety and effectiveness not established in pediatric patients.
Ciltacabtagene Autoleucel
- Severity Level:
D
- Additional Notes: Theoretical risk based on moa; manufacturer does not recommend using
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Ciltacabtagene Autoleucel
Insufficient human data available.
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available. |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Ciltacabtagene Autoleucel
General-greater risk of severe adverse reactions in patients greater than 65 years.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- This medication may cause serious (even fatal) reactions (cytokine release syndrome-CRS, hemophagocytic lymphohistiocytosis-HLH/macrophage activation syndrome-MAS). Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection.<br /><br />Tell your doctor right away if you have any symptoms such as high fever, trouble breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness, or signs of kidney problems (such as change in the amount of urine). Serious (even fatal) nerve problems can occur after treatment with ciltacabtagene autoleucel. Nerve problems can occur days or weeks after you receive this medication.<br /><br />Tell your doctor right away if you have mental/mood changes (such as confusion, anxiety, memory loss), drowsiness, seizure, tremor, loss of coordination, numbness/tingling/pain of the hands or feet, leg or arm weakness, facial numbness, difficulty moving the muscles of the face or eyes, or trouble with reading, writing, speaking, or understanding. This product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse.<br /><br />Tell your doctor right away if you have signs of infection (such as a sore throat that doesn't go away, fever, chills, cough), easy or unusual bruising/bleeding, or unusual tiredness. For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Carvykti REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
| Multiple myeloma | |
| C90.0 | Multiple myeloma |
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
| 0-9 | A-Z |
|---|---|
| C90.0 | Multiple myeloma |
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
Formulary Reference Tool