Thyrogen (Thyrotropin Alfa Recombinant) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 given 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.

Reactions reported in ≥ 1% of patients in the combined trials are summarized in Table 1.  In some studies, an individual patient may have participated in both THYROGEN and thyroid hormone withdrawal [ see Clinical Studies ( 14.1 ) ( 14.2) ].

Table 1: Summary of Adverse Reactions by THYROGEN and Thyroid Hormone Withdrawal in Pooled Clinical Trials (≥1% of Patients in any Phase)

Preferred Term	THYROGEN (N=481) n (%)	Thyroid Hormone Withdrawal  (N=418) n (%)
Nausea	53 (11)	2 (<1)
Headache	29 (6)	0
Fatigue	11 (2)	2 (<1)
Vomiting	11 (2)	0
Dizziness	9 (2)	0 (0.0)
Asthenia	5 (1)	1 (<1)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of THYROGEN.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Transient (<48 hours) influenza-like symptoms, including fever (>100°F/38°C), chills/shivering, myalgia/arthralgia, fatigue/asthenia/malaise, headache, and chills.
• Hypersensitivity including urticaria, rash, pruritus, flushing, and respiratory signs and symptoms.

REPORTS OF SUSPECTED THYROGEN SIDE EFFECTS / ADVERSE REACTIONS

Possible Thyrogen side effects / adverse reactions in 65 year old female

Reported by a consumer/non-health professional from Australia on 2011-11-30

Patient: 65 year old female

Reactions: Lung Consolidation, Dyspnoea, Stridor, Pain, Tracheal Disorder, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Radioactive Iodine Solution
    Dosage: 4000 mbq, unk
    Indication: Thyroid Cancer

Thyrogen
    Indication: Thyroid Cancer

Possible Thyrogen side effects / adverse reactions in 34 year old female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 34 year old female weighing 55.3 kg (121.7 pounds)

Reactions: Movement Disorder, Vomiting, Nausea, Anaemia, Visual Acuity Reduced, Speech Disorder, White Blood Cell Count Abnormal, Hearing Impaired, Decreased Appetite

Adverse event resulted in: hospitalization

Suspect drug(s):
Thyrogen

Possible Thyrogen side effects / adverse reactions in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-02-02

Patient: 47 year old female

Reactions: Lymphadenopathy, Inner Ear Disorder, Lymph Nodes Scan Abnormal, Hypertension

Suspect drug(s):
Thyrogen

Other drugs received by patient: Levothroid; Lamictal; Vitamin D; Seroquel