thyrogen
Pharmaranks rates Thyrogen 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Thyrogen (Thyrotropin Alfa) is a thyroid stimulating hormone used to treat Thyroid Neoplasms.
Thyrotropin Alfa · by Genzyme
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Thyrotropin Alfa
- Drug class
- Thyroid Stimulating Hormone
- Form
- Injectable
- Strength
- Thyrotropin Alfa 1.1MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- thyroid neoplasms
- Manufacturer
- Genzyme
- FDA application
- BLA020898
What is Thyrogen?
From the FDA label:Thyrotropin alfa, a recombinant human thyroid stimulating hormone, is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary TSH. Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line. Both thyrotropin alfa and naturally occurring human pituitary TSH are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is secreted as a mixture of sialylated and sulfated forms, thyrotropin alfa is sialylated but not sulfated. The biological activity of thyrotropin alfa is determined by a cell-based bioassay. In this assay, cells expressing a functional TSH receptor and a cAMP-responsive element coupled to a heterologous reporter gene, luciferase, enable the measurement of thyrotropin alfa activity by measuring the luciferase response. The specific activity of thyrotropin alfa is determined relative to an internal Genzyme reference standard that was calibrated against the World Health Organization (WHO) human TSH reference standard. THYROGEN (thyrotropin alfa) for injection is a sterile, white to off-white lyophilized powder in a single-dose vial for…
How to use
THYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer. ( 2.1 ) A two-injection regimen is recommended: THYROGEN 0.9 mg is administered intramuscularly, followed by a second 0.9 mg intramuscular injection 24 hours later. ( 2.1 ) 2.1 Recommended Dosage THYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer. THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9 mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later. THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously. Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures [see Warnings and Precautions (5.3) ] . Routine measurement of serum TSH levels is not recommended after THYROGEN use. 2.2 Reconstitution, Preparation, and Administration of THYROGEN The supplied lyophilized powder must be reconstituted with Sterile Water for Injection, USP. THYROGEN should be prepared, and administered in the following manner: Reconstitute each 0.9 mg vial of THYROGEN with 1.2 mL of Sterile Water for Injection, USP to yield a single-dose solution containing 0.9 mg/mL of thyrotropin alfa that delivers 1 mL (0.9 mg).…
Side effects
The most common adverse reactions (>5%) reported in clinical trials were nausea and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to THYROGEN in 481 thyroid cancer patients who participated in a total of 6 clinical trials of THYROGEN: 4 trials for diagnostic use and 2 trials for ablation. In clinical trials, patients had undergone near-total thyroidectomy and had a mean age of 46.1 years. Thyroid cancer diagnosis was as follows: papillary (69.2%), follicular (12.9%), Hurthle cell (2.3%) and papillary/follicular (15.6%). Most patients received 2 intramuscular injections of 0.9 mg of THYROGEN injection gin 24 hours apart [see Clinical Studies (14.1 , 14.2) ] . The safety profile of patients who have undergone thyroidectomy and received THYROGEN as adjunctive treatment for radioiodine ablation of thyroid tissue remnants for well-differentiated thyroid cancer did not differ from that of patients who received THYROGEN for diagnostic purposes.…
Warnings
Important safety information
THYROGEN-induced hyperthyroidism: Hospitalization for administration of THYROGEN and postadministrative observation should be considered for patients at risk. ( 5.1 ) Stroke: Stroke in female patients as well as other neurologic events in patients with central nervous system metastases. ( 5.2 , 5.3 ) Sudden rapid tumor enlargement: Sudden, rapid and painful enlargement in distant metastatic thyroid cancer. ( 5.3 ) Risks associated with radioiodine (RAI) combination treatment: If THYROGEN is administered with RAI, the warnings and precautions for RAI also apply to this combination regimen. ( 5.4 ) 5.1 THYROGEN-Induced Hyperthyroidism When given to patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, THYROGEN is known to cause a transient (over 7 to 14 days) but significant rise in serum thyroid hormone concentration. There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of THYROGEN. Patients with residual thyroid tissue at risk for THYROGEN-induced hyperthyroidism include the elderly and those with a known history of heart disease. Hospitalization for administration of THYROGEN and postadministration observation in patients at risk should be considered. 5.2 Stroke There are postmarketing reports of radiologically-confirmed stroke and neurological findings suggestive of stroke unconfirmed radiologically (e.g., unilateral weakness) occurring within 72 hours (range 20 minutes to three days) of THYROGEN administration in patients without known central nervous system metastases. The majority of such patients were young women taking oral contraceptives at the time of their event or had other risk factors for stroke, such as smoking or a history of migraine headaches. The relationship between THYROGEN administration and stroke is unknown. Patients should be well-hydrated prior to treatment with THYROGEN. 5.3 Sudden Rapid Tumor Enlargement Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with THYROGEN. This may lead to acute symptoms, which depend on the anatomical location of the tissue. Such symptoms include acute hemiplegia, hemiparesis, and loss of vision one to three days after THYROGEN administration. Laryngeal edema, pain at the site of distant metastasis, and respiratory distress requiring tracheotomy have also been reported after THYROGEN administration. Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures. 5.4 Risks Associated with Radioiodine Treatment If THYROGEN is administered with radioiodine (RAI), the warnings and precautions for RAI, apply to this combination regimen. Refer to the RAI prescribing information for a full list of the warnings and precautions for RAI.
Who should not take Thyrogen
If THYROGEN is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. Refer to the radioiodine prescribing information for a list of contraindications for radioiodine. If THYROGEN is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. ( 4 )
Overdose — what happens if you take too much
In clinical trials of THYROGEN, three patients experienced symptoms after receiving THYROGEN doses higher than those recommended. Two patients had nausea after a 2.7 mg IM dose (3 times the recommended dose), and in one of these patients, the event was accompanied by weakness, dizziness and headache. Another patient experienced nausea, vomiting and hot flashes after a 3.6 mg IM dose (4 times the recommended dose). There is no specific therapy for THYROGEN overdose. Supportive care is recommended.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Storing Thyrogen, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store THYROGEN refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.”
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Thyrogen treat?
- Thyrogen (Thyrotropin Alfa) may be used to treat thyroid neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Thyrogen rated?
- pharmaranks gives Thyrogen a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Thyrogen?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Thyrogen. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Thyrogen?
- Thyrogen is marketed by Genzyme. You can see Genzyme's full profile, rating, and other products on pharmaranks.
- Is Thyrogen a brand-name or generic drug?
- Thyrogen is a brand-name product with the active ingredient Thyrotropin Alfa.
- Is Thyrogen available over the counter?
- No. Thyrogen is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Thyrogen come in?
- Thyrogen is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Thyrogen?
- Thyrogen is classified as thyroid stimulating hormone, per the FDA's Established Pharmacologic Class.
- Is Thyrogen FDA-registered?
- Thyrogen is on record with the U.S. FDA under application number BLA020898. You can verify this on its official FDA label.
- Has Thyrogen been recalled by the FDA?
- Yes. Thyrogen has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Thyrogen safe?
- There's no single safe-or-not verdict. pharmaranks gives Thyrogen a recall-safety score of 72/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Thyrogen?
- Thyrogen's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (>5%) reported in clinical trials were nausea and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about THYROTROPIN ALFA
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 79 reports naming THYROTROPIN ALFA — the active ingredient in Thyrogen, and the FDA flagged 38% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- drug administered at inappropriate site8 reports
- headache8 reports
- nausea7 reports
- blood thyroid stimulating hormone decreased6 reports
- fatigue5 reports
- dyspnoea4 reports
- macular degeneration4 reports
- chest pain3 reports
Read these as a signal, not a rate. A report does not mean THYROTROPIN ALFA caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
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thyrogen
72/100