Thyrogen Use and Administration

Reconstitution

Reconstitute each vial of lyophilized powder with 1.2 ml of sterile water for injection.

Reconstitute immediately prior to use.

If necessary, the reconstituted solution can be stored for up to 24 hours at a temperature between 2°C and 8°C, while avoiding microbial contamination.

Visually inspect the Thyrogen solution for a particulate matter or discoloration prior to use. Any vials exhibiting particulate matter or discoloration should not be used.

Withdraw 1.0 ml (0.9 mg thyrotropin alfa) for intramuscular injection.

Each vial of Thyrogen solution and each vial of diluent (if provided) is intended for single use; discard any unused portions.

Storage

Thyrogen should be stored at 36°F to 46°F (2°C to 8°C).

It is recommended that Thyrogen be reconstituted immediately prior to use.

DO NOT USE THYROGEN AFTER THE EXPIRATION DATE ON THE VIAL.

Thyrogen should be protected from light.

Administration and Dosing

The following protocol¹ is recommended for testing with Thyrogen (rhTSH)¹:

Day 1	Day 2	Day 3	Day 4	Day 5
rhTSH 0.9 mg	rhTSH 0.9 mg	131I (if WBS)		Serum Tg with or without WBS

0.9 mg IM Thyrogen dose q24 hours for 2 doses (days1 and 2)

If performing a whole-body scan (WBS), 4 mCi of 131I is given on day 3 (24 hours after the last rhTSH injection)

• Serum Tg is measured on day 5 (72 hours after the last rhTSH injection) since this was the time at which mean Tg levels peaked2

• Serum Tg protocol is identical for both Tg testing alone and or when combined with WBS

• WBS is performed on day 5 (72 hours after the last rhTSH injection)

• WBS should be acquired for at least 30 minutes and/or should contain > 140,000 counts Note: While TSH levels were measured at various time points in clinical trials, the Thyrogen protocol does not require a TSH measurement.

Download a PDF of our new Reconstitution and Administration Guide (PDF).

Safety and tolerability

The most common adverse events reported in clinical trials with Thyrogen were:

Nausea (11%)

Headache (7%)

Asthenia (3%)

Vomiting (2%)

Several reactions of hypersensitivity consisting of urticaria, rash, pruritus, and flushing have also been reported. In clinical trials, no patients developed antibodies to thyrotropin alfa after either single or (in 27 cases) repeated use of the product.

Four patients (7%) with CNS metastases who were in a special treatment protocol experienced acute hemiplegia, hemiparesis, or pain 1 to 3 days after Thyrogen administration. In addition, there was one reported case of acute visual loss and one of dysphagia secondary to laryngeal edema, requiring tracheotomy. Both were reported 24 hours after the administration of Thyrogen in patients with metastases to the optic nerve and paratracheal areas, respectively. Pretreatment with corticosteroids may be considered in this setting. Finally, one 77-year-old nonthyroidectomized man with a history of heart disease and spinal metastases suffered a fatal myocardial infarction 24 hours after receiving the last of four Thyrogen injections, which had been administered over 6 days in a special treatment protocol. The event was likely related to Thyrogen-induced hyperthyroidism.

For more information, please see the full prescribing information (PDF).