Medical Use
Zydelig is a prescription medication approved for the treatment of chronic lymphocytic leukemia (CLL) that has relapsed, meaning it has returned or worsened after previous treatments.
Zydelig is administered alongside rituximab (Rituxan) and is prescribed for adults who can only receive rituximab due to other health conditions. It is important to note that Zydelig is not intended for use as a first-line treatment for CLL, which refers to the initial therapy given for the condition.
Warning & Precautions
Hepatotoxicity: Fatal and/or serious liver toxicity occurred in 16% of patients treated with ZYDELIG in combination with rituximab or other unapproved therapies. These effects were typically seen within the first 12 weeks of treatment and improved with dose interruption. Upon restarting at a lower dose, ALT/AST levels rose again in 26% of patients. Monitor ALT/AST every 2 weeks for the first 3 months, then every 4 weeks for the next 3 months, and every 1 to 3 months thereafter. If ALT/AST levels exceed 3 times the upper limit of normal (ULN), monitor for liver toxicity weekly. If levels exceed 5 times ULN, stop ZYDELIG and monitor ALT/AST and total bilirubin weekly until resolved. Discontinue ZYDELIG for recurrent liver toxicity. Avoid using other hepatotoxic drugs concurrently.
Severe Diarrhea or Colitis: Severe diarrhea or colitis (Grade ≥3) occurred in 20% of patients treated with ZYDELIG in combination with rituximab or other unapproved therapies. Grade 3+ diarrhea can occur at any time and does not respond well to antimotility agents. Avoid using other drugs that cause diarrhea concurrently.
Pneumonitis: Fatal and serious pneumonitis occurred in 4% of patients treated with ZYDELIG, compared to 1% in comparator arms of randomized clinical trials. Onset ranged from less than 1 month to 15 months. Symptoms included interstitial infiltrates and organizing pneumonia. Monitor for pulmonary symptoms. If patients present with symptoms like cough, dyspnea, hypoxia, interstitial infiltrates on radiologic exams, or a decline in oxygen saturation by more than 5%, interrupt ZYDELIG until the cause is determined. If symptomatic pneumonitis or organizing pneumonia is diagnosed, treat with corticosteroids and permanently discontinue ZYDELIG.
Infections: Fatal and/or serious infections occurred in 48% of patients treated with ZYDELIG in combination with rituximab or other unapproved therapies. Common infections included pneumonia, sepsis, and febrile neutropenia. Treat infections before starting ZYDELIG and interrupt ZYDELIG for Grade 3 or higher infections. Serious or fatal Pneumocystis jirovecii pneumonia (PJP) or cytomegalovirus (CMV) occurred in less than 1% of patients. Provide PJP prophylaxis during treatment. Interrupt ZYDELIG for suspected PJP and permanently discontinue if confirmed. Monitor for CMV infection in patients with a history of CMV or positive CMV serology at the start of treatment. Interrupt ZYDELIG if CMV PCR or antigen test is positive until resolved. If ZYDELIG is resumed, monitor for CMV reactivation monthly.
Intestinal Perforation: Advise patients to report any new or worsening abdominal pain, chills, fever, nausea, or vomiting. Permanently discontinue ZYDELIG in patients who experience intestinal perforation.
Severe Cutaneous Reactions: Fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have occurred. Cases of drug reaction with eosinophilia and systemic symptoms (DRESS) have also been reported. If suspected, interrupt ZYDELIG until the cause is determined. If SJS, TEN, or DRESS is confirmed, permanently discontinue ZYDELIG. Monitor for other severe or life-threatening (Grade ≥3) skin reactions and discontinue ZYDELIG if they occur.
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported. ZYDELIG is contraindicated in patients with a history of serious hypersensitivity reactions to idelalisib. Permanently discontinue ZYDELIG and provide appropriate supportive measures if a reaction occurs.
Neutropenia: Grade 3-4 neutropenia occurred in 58% of patients. Monitor blood counts every 2 weeks for the first 6 months, and weekly if neutrophil counts are below 1.0 Gi/L. Interrupt ZYDELIG until resolved and resume at a reduced dose.
Embryo-Fetal Toxicity: ZYDELIG may cause fetal harm. Females who are or become pregnant while taking ZYDELIG should be informed of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 1 month after stopping ZYDELIG.
Documentation Availability
Documents required to import ZYDELIG to India?
Zydelig can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- (i)2 ID proofs along with PAN card details along with attested scanned copies
- (ii)Valid doctor prescription scanned copy
- (iii)Doctor’s MCI number
- (iv)Doctor’s mobile number
- (v)Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- (i)The above-mentioned documents and drug availability.
- (ii)Import permit if applicable.
Sourcing & Delivery
The Rx4U team has extensive experience in sourcing ZYDELIG Idelalisib (Cancer Treatment Medicines) from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.
FAQ
What is the generic name for the trade name drug Zydelig?
The generic name for Zydelig is idelalisib.
Who manufactures Zydelig?
Zydelig is produced by Gilead Sciences, Inc.
Is Zydelig FDA approved?
Yes, Zydelig received FDA approval on July 23, 2014.
What dosage and form is Zydelig available in?
Zydelig is available in the form of 100mg tablets.
*Disclaimer
All Trademarks and Brands that appear on the website belong to their respective owners and Rx4U does not lay any claim on them we only provide Information.
