Cytarabine Liposomal ARA-C Brand Name– DepoCyt
What is Cytarabine Liposomal ARA-C
Cytarabine (cytosine arabinoside, Ara-C) is a pyrimidine antimetabolite agent. In the liposomal product (DTC-101), cytarabine is encapsulated into multivesicular lipid-based particles, a liposome (DepoFoam™).
The DepoFoam™ delivery system consists of microscopic, spherical, foam-like particles composed of internal, nonconcentric chambers encapsulating cytarabine.
A biodegradable, bilayer lipid membrane that is made up of synthetic endogenous lipids separates individual chambers.
The membrane of DepoFoam™ consists of dioleoyl lecithin, dipalmitoyl phosphatidylglycerol, cholesterol, and triolein. Greater efficacy is obtained and less frequent dosing is needed with liposomal cytarabine as compared with conventional cytarabine.
Cytarabine liposomal, ARA-C is indicated for the intrathecal treatment of lymphomatous meningitis. It is administered intrathecally once every two weeks whereas conventional cytarabine is administered twice per week. Of 17 patients with lymphoma, 41% (95% CI, 18%—67%) had an absence of malignant cells in the CSF and an absence of neurological progression after 4 weeks of cytarabine liposomal, ARA-C whereas only 6% (95% CI, 0%—30%) of 16 patients treated with conventional cytarabine met the endpoint.
Similar results were obtained in a second trial. In April 1999, the FDA approved liposomal cytarabine for the treatment of lymphomatous meningitis under the Accelerated Approval regulations of Subpart H of the Food, Drug, and Cosmetic Act.
In April 2007, full approval was granted by the FDA.
Indications
- carcinomatous meningitis
For the treatment of carcinomatous meningitis
NOTE: Cytarabine liposomal has been designated an orphan drug by the FDA for this indication.
Side Effects
- abdominal pain
- agitation
- anemia
- anorexia
- anxiety
- arachnoiditis
- arthralgia
- back pain
- blurred vision
- confusion
- constipation
- cough
- cranial nerve palsies
- dehydration
- depression
- diarrhea
- dizziness
- drowsiness
- dysphagia
- dyspnea
- edema
- encephalopathy
- fatigue
- fever
- headache
- hearing loss
- hemorrhoids
- hydrocephalus
- hyperglycemia
- hyperhidrosis
- hypertension
- hypoesthesia
- hypokalemia
- hyponatremia
- hypotension
- infection
- insomnia
- lethargy
- memory impairment
- nausea
- neutropenia
- paresthesias
- peripheral edema
- peripheral neuropathy
- pruritus
- seizures
- sinus tachycardia
- syncope
- thrombocytopenia
- tremor
- urinary incontinence
- urinary retention
- visual impairment
- vomiting
- weakness
Monitoring Parameters
- neurologic function
Contraindications
- arachnoiditis
- breast-feeding
- children
- infants
- infection
- neonates
- peripheral neuropathy
- pregnancy
- radiation therapy
Interactions
There are no drug interactions associated with Cytarabine Liposomal, ARA-C products.
