Loading…
THYROGEN is a brand name for Thyrotropin Alfa, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: THYROGEN ® (thyrotropin alfa for injection) is indicated for: • use as an adjunctive treatment as pre-therapeutic stimulation for radioiodine ablation of thyroid tissue remnants in patients maintained on thyroid hormone suppression therapy who have undergone a near-total or total thyroidectomy for well-differentiated…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Thyrogen® (thyrotropin alfa for injection) injections should be supervised by a healthcare professional knowledgeable in the management of thyroid cancer. • Thyrogen® should be administered intramuscularly only.
It should not be administered intravenously. 2 Recommended Dose and Dosage Adjustment A two-injection regimen is recommended for Thyrogen® administration. 9 mg IM injection 24 hours later. 9 mg thyrotropin alfa), Thyrogen® is administered by intramuscular injection in the gluteal muscle.
No pediatric data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Thyrogen® has to be reconstituted with Sterile Water for Injection. Only one vial of Thyrogen® is required per injection.
2 mL of Sterile Water for Injection, USP, to the Thyrogen® powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. 9 mg thyrotropin alfa per mL. Reconstituted Thyrogen® solution should be a clear, colourless solution.
Do not use vials exhibiting foreign particles, cloudiness or discoloration. 5. 0 mL of the Thyrogen® solution from the product vial. 9 mg thyrotropin alfa to be injected. Thyrogen® does not contain preservatives. The Thyrogen® solution should be injected within three hours, however the Thyrogen® solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2-8oC).
It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution. Each vial of Thyrogen® and each vial of diluent is intended for single use. Discard unused materials. Thyrogen® injection material should not be mixed with other substances.
4 Administration Thyrogen® (thyrotropin alfa for injection) should be administered intramuscularly only. 5 Missed Dose Not applicable. 6 Image Acquisition and Interpretation The following parameters were utilized in the second Phase 3 study and these parameters are recommended for radioimaging scanning: • For radioiodine imaging or treatment, radioiodine administration should be given 24 hours following the final Thyrogen® injection.
Diagnostic scanning should be performed 48 hours after radioiodine administration whereas post-therapy scanning may be delayed additional days to allow background activity to decline. • A diagnostic activity of 148 MBq (4mCi) 131I should be used.
1 Adverse Reaction Overview Adverse reaction data were derived from post-marketing surveillance and clinical trials. Table 3 below represents adverse reactions experienced by 62 thyroid cancer patients who participated in the clinical trials for Thyrogen® supporting the ablation indication (THYR-008-00 and THYR01605).
Table 4 below represents adverse reactions experienced by 381 thyroid cancer patients who participated in the clinical trials for Thyrogen® supporting the diagnostic indication (TSH92-0601 and TSH95-0101). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Three patients enrolled in clinical trials and/or the Compassionate Use Program developed thromboembolism. Amongst 152 patients in the diagnostic study TSH92-0601, one patient with extensive metastases had a fatal Pulmonary Embolism 8 days after receiving Thyrogen®.
Amongst 115 advanced cancer patients treated in the Compassionate Use Program, 2 had Deep Vein Thrombosis (DVT) AEs. There are several reports in the post-marketing database of DVT and/or Pulmonary Embolism in patients who received Thyrogen®.
One patient was on concomitant oral contraceptive therapy, and the other patients had prolonged hospitalization and/or extensive metastatic disease prior to the thromboembolic event. Remnant Ablation Indication Adverse reaction data for the remnant ablation indication are derived from 62 patients who received Thyrogen® as adjunctive treatment for radioiodine ablation of thyroid tissue remnants in THYR-008-00 and follow-up study THYR01605.
, General). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Thyrogen® (thyrotropin alfa for injection) should be administered intramuscularly only.
It should not be administered intravenously (see 7 WARNINGS AND PRECAUTIONS, General). 1 Dosing Considerations • Thyrogen® (thyrotropin alfa for injection) injections should be supervised by a healthcare professional knowledgeable in the management of thyroid cancer.
• Thyrogen® should be administered intramuscularly only. It should not be administered intravenously. 2 Recommended Dose and Dosage Adjustment A two-injection regimen is recommended for Thyrogen® administration. 9 mg IM injection 24 hours later.
9 mg thyrotropin alfa), Thyrogen® is administered by intramuscular injection in the gluteal muscle. No pediatric data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Thyrogen® has to be reconstituted with Sterile Water for Injection.
Only one vial of Thyrogen® is required per injection. 2 mL of Sterile Water for Injection, USP, to the Thyrogen® powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. 9 mg thyrotropin alfa per mL.
Reconstituted Thyrogen® solution should be a clear, colourless solution. Do not use vials exhibiting foreign particles, cloudiness or discoloration. 5. 0 mL of the Thyrogen® solution from the product vial. 9 mg thyrotropin alfa to be injected.
Thyrogen® does not contain preservatives. The Thyrogen® solution should be injected within three hours, however the Thyrogen® solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2-8oC). It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Thyrogen® (thyrotropin alfa for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container or component of the container (see 7 WARNINGS AND PRECAUTIONS, General).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• Whole body images should be acquired for a minimum of 30 minutes and/or should contain a minimum of 140,000 counts. e. 60,000 for a large field of view camera, 35,000 counts for a small field of view). For radioiodine ablation of thyroid tissue remnants, the activity of 131I is carefully selected at the discretion of the nuclear medicine physician.
For serum Tg testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen®.
In the THYR-008-00 study, patients were randomized to either the hypothyroid or euthyroid group after thyroidectomy. 7 GBq ± 10%; 100 mCi) administered on the following day. Patients randomised to the Hypothyroid Group did not receive Thyrogen® prior to ablation.
7 GBq ± 10%; 100 mCi) was administered. 9 mg IM once a day x 2 days for diagnostic purposes. Adverse events were collected in the Euthyroid group for the entire 8-month period including 5 days after the diagnostic dose of Thyrogen®. 4 years) following radioiodine ablation.
Therefore, the study has limited long-term safety data. 1%). All adverse events reported in the THYR01605 trial occurred in only one patient. 7%. Events reported in patients in the trials are summarized in Table 3. 0) […]
Each vial of Thyrogen® and each vial of diluent is intended for single use. Discard unused materials. Thyrogen® injection material should not be mixed with other substances. 4 Administration Thyrogen® (thyrotropin alfa for injection) should be administered intramuscularly only.
5 Missed Dose Not applicable. 6 Image Acquisition and Interpretation The following parameters were utilized in the second Phase 3 study and these parameters are recommended for radioimaging scanning: • For radioiodine imaging or treatment, radioiodine administration should be given 24 hours following the final Thyrogen® injection.
Diagnostic scanning should be performed 48 hours after radioiodine administration whereas post-therapy scanning may be delayed additional days to allow background activity to decline. • A diagnostic activity of 148 MBq (4mCi) 131I should be used.
• Whole body images should be acquired for a minimum of 30 minutes and/or should contain a minimum of 140,000 counts. e. 60,000 for a large field of view camera, 35,000 counts for a small field of view). For radioiodine ablation of thyroid tissue remnants, the activity of 131I is carefully selected at the discretion of the nuclear medicine physician.
For serum Tg testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen®. 5 OVERDOSAGE Data on exposure above the recommended dose is limited to clinical studies and a special treatment program. Three patients in clinical trials, and one patient in the special treatment program experienced symptoms after receiving Thyrogen® (thyrotropin alfa for injection) doses higher than those recommended.
7 mg IM dose, and in one of these patients, the event was accompanied by weakness, dizziness and headache. 6 mg IM dose. 9 mg over 6 days, developed atrial fibrillation, cardiac decompensation and terminal myocardial infarction 2 days later.
3 mg Thyrogen® as a single IV bolus, experienced severe nausea, vomiting, diaphoresis, hypotension (BP decreased from 115/66 mm Hg to 81/44 mm Hg) and tachycardia (pulse increased from 75 to 117 bpm) 15 minutes after injection. When necessary, symptomatic treatment should be considered for potential cardiac symptoms.
In case of overdose, assessment of fluid balance and administration of fluids and/or an antiemetic may be considered. For management of a suspected drug overdose, contact your regional poison control centre. THYROGEN® (thyrotropin alfa) Product Monograph Page 9 of 51 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Thyrogen® (thyrotropin alfa for injection) is supplied as a sterile, non-pyrogenic lyophilized product.
1 mg vials (7-26 IU/mg) Thyrogen®(see 13 PHARMACEUTICAL INFORMATION). 4 mg Dibasic, […]