Tepadina

Tepadina

thiotepa

Manufacturer:

Adienne SA

Distributor:

Hind Wing
/
Four Star
Concise Prescribing Info
Contents
Thiotepa
Indications/Uses
Conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cells transplantation (HPCT) in haematological diseases, w/ or w/o total body irradiation. Treatment of solid tumours when high dose chemotherapy w/ HPCT support is appropriate.
Dosage/Direction for Use
Adult Autologous HPCT Haematological diseases & lymphoma 125-300 mg/m2/day (3.38-8.1 mg/kg/day) as a single daily infusion, administered from 2-4 consecutive days before autologous HPCT. Max: 900 mg/m2 (24.32 mg/kg). CNS lymphoma 185 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT. Max: 370 mg/m2 (10 mg/kg). Multiple myeloma 150-250 mg/m2/day (4.05-6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT. Max: 750 mg/m2 (20.27 mg/kg). Solid tumours 120-250 mg/m2/day (3.24-6.76 mg/kg/day) divided in 1 or 2 daily infusions, administered from 2-5 consecutive days before autologous HPCT. Max: 800 mg/m2 (21.62 mg/kg). Breast cancer 120-250 mg/m2/day (3.24-6.76 mg/kg/day) as a single daily infusion, administered from 3-5 consecutive days before autologous HPCT. Max: 800 mg/m2 (21.62 mg/kg). CNS tumours 125-250 mg/m2/day (3.38-6.76 mg/kg/day) divided in 1 or 2 daily infusions, administered from 3-4 consecutive days before autologous HPCT. Max: 750 mg/m2 (20.27 mg/kg). Ovarian cancer 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered in 2 consecutive days before autologous HPCT. Max: 500 mg/m2 (13.51 mg/kg). Germ cell tumours 150-250 mg/m2/day (4.05-6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT. Max: 750 mg/m2 (20.27 mg/kg). Allogeneic HPCT Haematological diseases 185-481 mg/m2/day (5-13 mg/kg/day) divided in 1 or 2 daily infusions, administered from 1-3 consecutive days before allogeneic HPCT. Max: 555 mg/m2 (15 mg/kg). Lymphoma 370 mg/m2/day (10 mg/kg/day) divided in 2 daily infusions before allogeneic HPCT. Max: 370 mg/m2 (10 mg/kg). Multiple myeloma 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT. Max: 185 mg/m2 (5 mg/kg). Leukemia 185-481 mg/m2/day (5-13 mg/kg/day) divided in 1 or 2 daily infusions, administered from 1-2 consecutive days before allogeneic HPCT. Max: 555 mg/m2 (15 mg/kg). Thalassemia 370 mg/m2/day (10 mg/kg/day) divided in 2 daily infusions, administered before allogeneic HPCT. Max: 370 mg/m2 (10 mg/kg). Childn Autologous HPCT Solid Tumours 150-350 mg/m2/day (6-14 mg/kg/day) as a single daily infusion, administered from 2-3 consecutive days before autologous HPCT. Max: 42 mg/kg). CNS Tumours 250-350 mg/m2/day (10-14 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT. Max: 1,050 mg/m2 (42 mg/kg). Allogeneic HPCT Haematological diseases 125-250 mg/m2/day (5-10 mg/kg/day) divided in 1 or 2 daily infusions, administered from 1-3 consecutive days before allogenic HPCT. Max: 375 mg/m2 (15 mg/kg). Leukemia 250 mg/m2/day (10 mg/kg/day) divided in 2 daily infusions, administered before allogeneic HPCT. Max: 250 mg/m2 (10 mg/kg). Thalassemia 200-250 mg/m2/day (8-10 mg/kg/day) divided in 2 daily infusions, administered before allogeneic HPCT. Max: 250 mg/m2 (10 mg/kg). Refractory cytopenia 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT. Max: 375 mg/m2 (15 mg/kg). Genetic diseases 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT. Max: 250 mg/m2 (10 mg/kg). Sickle cell anaemia 250 mg/m2/day (10 mg/kg/day) divided in 2 daily infusions, administered before allogeneic HPCT. Max: 250 mg/m2 (10 mg/kg).
Contraindications
Hypersensitivity. Pregnancy & lactation. Concomitant use w/ yellow fever vaccine & w/ live virus & bacterial vaccines.
Special Precautions
Myelosuppression. Perform complete blood counts during the treatment, until recovery is achieved &/or after transplant for at least 30 days. Prophylactic or empiric use of anti-infectives for prevention & management of infections during the neutropenic period. Hepatic impairment. Monitor serum transaminase, alkaline phosphatase & bilirubin regularly following transplant. Patients who received prior radiation therapy, ≥3 cycles of chemotherapy or prior progenitor cell transplant. History of cardiac & renal diseases. Monitor cardiac & renal function during thiotepa therapy. May induce pulmonary toxicity. Previous brain or craniospinal irradiation. Increased risk of secondary malignancy. Concomitant use w/ live attenuated vaccines (except yellow fever vaccines), phenytoin & fosphenytoin. Concurrent administration w/ cyclophosphamide. Concomitant of CYP2B6 or CYP3A4. May impair male or female fertility. May impair ability to drive or operate machinery.
Adverse Reactions
Increased infection susceptibility, sepsis; leukopenia, thrombocytopenia, febrile neutropenia, anaemia, pancytopenia, granulocytopenia; acute or chronic graft versus host disease; anorexia, decreased appetite, hyperglycaemia; confusional state, mental status changes, dizziness, headache, blurred vision, encephalopathy, convulsion, paraesthesia; conjunctivitis; impaired hearing, ototoxicity, tinnitus; arrhythmia, tachycardia, cardiac failure; lymphoedema, HTN; idiopathic pneumonia syndrome, epistaxis; nausea, stomatitis, oesophagitis, vomiting, diarrhoea, dyspepsia, abdominal pain, enteritis, colitis; veno-occlusive liver disease, hepatomegaly, jaundice; rash, pruritus, alopecia; back pain, myalgia, athralgia; haemorrhagic cystitis; azoospermia, amenorrhoea, vag haemorrhage; pyrexia, asthenia, chills, generalised oedema, inj site pain & inflammation, mucosal inflammation; increased wt, increased blood bilirubin, amylase & transaminases. Paed population: Increased infection susceptibility, sepsis, thrombocytopenia, febrile neutropenia, anaemia, pancytopenia, granulocytopenia, acute graft versus host disease, chronic graft versus host disease, hypopituitarism, hypogonadism, hypothyroidism, anorexia, hyperglycaemia, mental status changes, headache, encephalopathy, convulsion, cerebral haemorrhage, memory impairment, paresis, impaired hearing, cardiac arrest, haemorrhage, pneumonitis, nausea, stomatitis, vomiting, diarrhoea, abdominal pain, venoocclusive liver disease, rash, erythema, desquamation, pigmentation disorder, growth retardation, bladder disorders, pyrexia, mucosal inflammation, pain, multi-organ failure; increased blood bilirubin, transaminases, blood creatinine, AST, ALT.
Drug Interactions
Increased plasma conc w/ CYP2B (eg, clopidogrel & ticlopidine) or CYP3A4 inhibitors (eg, azole antifungals, macrolides & protease inhibitors). Increased plasma conc of active metabolite w/ CYP450 inducers (eg, rifampicin, carbamazepin, phenobarb). Increased plasma conc of ifosfamide, tamoxifen, bupropion, efavirenz & cyclophosphamide. Decreased conc of active cyclophosphamide metabolite. Risk of fatal generalized vaccine-induced disease w/ yellow fever vaccine. Risk of systemic, possibly fatal disease w/ live attenuated vaccines (except yellow fever). Risk of exacerbation of convulsion due to decreased phenytoin digestive absorption. Risk of toxicity enhancement & loss of efficacy due to increased hepatic metabolism by phenytoin. Excessive immunosuppression w/ risk of lymphoproliferation w/ ciclosporine & tacrolimus. Prolonged action of succinylcholine. May potentiate the risk of haematologic adverse reactions w/ other myelosuppressive or myelotoxic agents (ie, cyclophosphamide, melphalan, busulfan, fludarabine, treosulfan). Increased thrombotic risk w/ anticoagulant treatment.
ATC Classification
L01AC01 - thiotepa ; Belongs to the class of alkylating agents, ethylene imines. Used in the treatment of cancer.
Presentation/Packing
Form
Tepadina powd for infusion 15 mg
Packing/Price
1's
Form
Tepadina powd for infusion 100 mg
Packing/Price
1's
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