Holoxan 1 gm/vial is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with Mesna for prophylaxis of hemorrhagic cystitis.
Theropeutic Class
Cytotoxic Chemotherapy
Pharmacology
Holoxan 1 gm/vial is converted to its active metabolites via hepatic microsomal enzymes. These active metabolites act as alkylating agents, disrupting DNA and protein synthesis of the target cells. It is routinely given with mesna to reduce urothelial toxicity.
Dosage & Administration of Holoxan 1 gm/vial
Lymphoma, Sarcoma, Solid tumours: Different licensed dosage regimens are available.
Regimen 1: 8-12 gm/m2 divided over 3-5 days, repeat course every 2-4 wk.
Regimen 2: 6 gm/m2 divided over 5 days, repeat course every 3 wk.
Regimen 3: 5-6 gm/m2 (max: 10 gm), give as a single 24-hr infusion, repeat course every 3-4 wkly.
Germ cell testicular carcinoma: 1.2 gm/m2/day for 5 days via slow infusion over at least 30 minutes, repeat treatment every 3 wk or after recovery from haematological toxicity. To be given with mesna and adequate hydration of at least 2 L of oral or IV fluid per day.
Dosage of Holoxan 1 gm/vial
Lymphoma, Sarcoma, Solid tumours: Different licensed dosage regimens are available.
Regimen 1: 8-12 gm/m2 divided over 3-5 days, repeat course every 2-4 wk.
Regimen 2: 6 gm/m2 divided over 5 days, repeat course every 3 wk.
Regimen 3: 5-6 gm/m2 (max: 10 gm), give as a single 24-hr infusion, repeat course every 3-4 wkly.
Germ cell testicular carcinoma: 1.2 gm/m2/day for 5 days via slow infusion over at least 30 minutes, repeat treatment every 3 wk or after recovery from haematological toxicity. To be given with mesna and adequate hydration of at least 2 L of oral or IV fluid per day.
Interaction of Holoxan 1 gm/vial
Causes enhanced toxicity with allopurinol, cisplatin. Holoxan 1 gm/vial enhances the anticoagulant effect of warfarin. CYP2A6 inducers (e.g. amobarbital, pentobarbital, phenobarbital, rifampin and secobarbital) may reduce serum levels of Holoxan 1 gm/vial while the inhibitors (e.g. isoniazid, methoxsalen and miconazole) may increase its serum levels. CYP3A4 inducers (e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins) may reduce serum levels of Holoxan 1 gm/vial while the inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid) may increase its serum levels.
Contraindications
Hypersensitivity; severe bone-marrow depression. Pregnancy, lactation.
Side Effects of Holoxan 1 gm/vial
Confusion, alopoecia, nausea, vomiting, phloebitis, somnolence, depression, hallucinations. Wound healing may be impaired during Holoxan 1 gm/vial use.Potentially Fatal: Severe myelosuppression, haemorrhagic cystitis, nephrotoxicity, cardiotoxicity, coma.
Pregnancy & Lactation
Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Precautions & Warnings
Hepatic or renal dysfunction, compromised bone marrow reserve. Use with mesna and ensure high oral/IV fluid intake to reduce urotoxic effects.
Storage Conditions
Store at 20-25° C.
Use In Special Populations
Renal Impairment: CrCl <10: Administer 75% of dose.
Reconstitution
Add 20 ml of sterile water for inj or sterile bacteriostatic water for inj containing benzyl alcohol or parabens for each 1 g of the drug to produce solutions of 50 mg/ml.
Drug Classes
Cytotoxic Chemotherapy
Mode Of Action
Holoxan 1 gm/vial is converted to its active metabolites via hepatic microsomal enzymes. These active metabolites act as alkylating agents, disrupting DNA and protein synthesis of the target cells. It is routinely given with mesna to reduce urothelial toxicity.
Pregnancy
Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Pediatric Uses
Renal Impairment: CrCl <10: Administer 75% of dose.
Frequently Asked Questions
What is Holoxan 1 gm/vial used for?
Holoxan 1 gm/vial is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with Mesna for prophylaxis of hemorrhagic cystitis.
What is the dosage of Holoxan 1 gm/vial?
Lymphoma, Sarcoma, Solid tumours: Different licensed dosage regimens are available. Regimen 1: 8-12 gm/m2 divided over 3-5 days, repeat course every 2-4 wk. Regimen 2: 6 gm/m2 divided over 5 days, repeat course every 3 wk. Regimen 3: 5-6 gm/m2 (max: 10 gm), give as a single 24-hr infusion, repeat course every 3-4 wkly. Germ cell testicular carcinoma: 1.2 gm/m2/day for 5 days via slow infusion over…
What are the side effects of Holoxan 1 gm/vial?
Confusion, alopoecia, nausea, vomiting, phloebitis, somnolence, depression, hallucinations. Wound healing may be impaired during Holoxan 1 gm/vial use.Potentially Fatal: Severe myelosuppression, haemorrhagic cystitis, nephrotoxicity, cardiotoxicity, coma.
Who should not take Holoxan 1 gm/vial?
Hypersensitivity; severe bone-marrow depression. Pregnancy, lactation.
What precautions should be taken with Holoxan 1 gm/vial?
Hepatic or renal dysfunction, compromised bone marrow reserve. Use with mesna and ensure high oral/IV fluid intake to reduce urotoxic effects.
Is Holoxan 1 gm/vial safe during pregnancy and breastfeeding?
Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.