Temoporfin- Carcino- Chemotherapeutic agents - (July 2008)
Drug Name:
Temoporfin- Carcino- Chemotherapeutic agents - (July 2008)
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
155. Temoporfin 1mg/ml Injection 08-07-08
Same as approved
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Temoporfin 1mg/ml injection 08-07-2008
Addl.Stgth
As approved
Pts with advanced head and neck squamous cell carcinoma failing prior therapies and those unsuitable for surgery
Adverse Reaction:
Adverse effects include pain, haemorrhage pain in face, injection site pain, scar, Mouth necrosis, dysphagia, face oedema, Constipation, vomiting, Anemia, trismus, loaclised infection, Fever, hyperpigmentation, Photosensitivity reaction & skin necrosis.
Contra-Indications:
Prophyrias, Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site
Planned surgical procedure within the next 30 days. coexisting ophthalmic diseases likely to require slit-lsamp examination within the next 30 days
Existing therapy with a photoosensitizing agent, pregnanct (first trimester)
Precautions-
Special care must be taken to prevent extravasation at injection site. If extrvastion ocurs protect the are from Light for at least 3 months, lactation.
Dosages/ Overdosage Etc:
Indication-
Pts with advanced head and neck squamous cell carcinoma failing prior therapies and those unsuitable for surgery
Dosage-
Administered at dosage of 0.15mg/kg and administered as a single slow intravenous injection.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Temoporofin like most photosensitizers binds to cellular membranes after intervenous adimintration & enters the cellular intestinal space. Mechanism of action- The anti-tumor activity of temporfin depends on photoactivation with light of 652 nm from a laser. The molecular basis of photosensitivity & photodynamic effects is fairly well understood. Absorption of photons by temoporfin results in the promotion of electrons to higher energy states
Pregnancy and lactation:
Contraindicated during first trimester of pregnancy.