Sunitinib Malate Capsules 12.5 Mg For Adult Patients With Thyroid Cancer

Sunitinib (SUTENT)
[Drug Name].

Generic Name: Sunitinib Malate Capsules

Trade name: Sultan®/Sutent®

English name: Sunitinib Malate Capsules

Hanyu Pinyin: Pingguosuan Shunitini JiaoNang

[Indications

Inoperable advanced renal cell carcinoma (RCC)

Gastrointestinal Mesenchymal Stromal Tumor (GIST) Failing or Intolerant Imatinib Mesylate Treatment

Unresectable, metastatic highly differentiated progressive pancreatic neuroendocrine tumor (pNET) in adult patients.

[Usage and dosage]

The recommended dose of this product for the treatment of gastrointestinal mesenchymal stromal tumors and advanced renal cell carcinoma is 50 mg orally once daily for 4 weeks and 2 weeks off (4/2 dosing regimen) until disease progression or intolerable toxicity occurs.

For pancreatic neuroendocrine tumors, the recommended dose of this product is 37.5 mg orally once daily until disease progression or intolerable toxicity occurs.

It can be taken with or without food.

Safety and tolerability

For gastrointestinal mesenchymal tumors and metastatic renal cell carcinoma, the dose is adjusted gradually in 12.5 mg gradient units based on individual patient safety and tolerability. The maximum daily dose should not exceed 75 mg and the minimum dose should be 25 mg.

For pancreatic neuroendocrine tumors, the dose is adjusted gradually in 12.5 mg gradient units based on individual patient safety and tolerability. The maximum dose used in the Phase 3 clinical trial was 50 mg daily.

Interruption of therapy may be required depending on the individual patient's safety and tolerability profile.

Dosage adjustments in case of drug interactions

Strong inhibitors of CYP3A4: Combinations should be made with drugs that have no or minimal inhibitory effect on these enzymes. If combining this product with a potent inhibitor of CYP3A4 cannot be avoided, consider reducing the dose of this product to the lowest dose described below.

Gastrointestinal mesenchymal stromal tumor (GIST) and advanced renal cell carcinoma (RCC): 37.5 mg orally, once daily, with a regimen of 4 weeks of dosing and 2 weeks of withdrawal (4/2 dosing regimen)

Pancreatic neuroendocrine tumor: 25 mg orally once daily.

CYP3A4 strong inducers: drugs with no or minimal induction of such enzymes should be selected for co-administration. If co-administration with a strong inducer of CYP3A4 cannot be avoided, consideration should be given to increasing the dose of this product to the maximum dose described below:

Gastrointestinal mesenchymal stromal tumor (GIST) and advanced renal cell carcinoma (RCC): 87.5 mg orally, once daily, with a regimen of 4 weeks of dosing and 2 weeks of withdrawal (4/2 dosing regimen)

Pancreatic neuroendocrine tumor: 62.5 mg orally once daily.

If the dose of this product is increased, patients should be carefully monitored for adverse reactions.

Dose Adjustment in Hemodialysis Patients with End-Stage Renal Disease (ESRD)

No starting dose adjustment is required for end-stage renal disease (ESRD) hemodialysis patients. However, given that patients with normal renal function

Decreased compared to the exposure, the maintenance dose can be gradually increased up to 2-fold depending on safety and tolerability.

[Adverse Reaction]

The most common adverse reactions (≥20%) in patients with gastrointestinal mesenchymal stromal tumors (GIST), advanced renal cell carcinoma (RCC), or pancreatic neuroendocrine tumors (pNET) were fatigue, malaise, fever, diarrhea, nausea, mucositis/ostomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, discoloration of the skin, dryness of the skin, hair color change, taste changes, headache, back pain, joint pain, limb pain, cough, dyspnea, anorexia and bleeding.

[Storage]

Store at 25°C; allowable range is 15-30°C.