applepharmaceutical@gmail.com
regorafenib-40mg

PRODUCT DETAILS

Composition : Regorafenib
Strength availability : 40mg
Pack : 28 tablets
for MORE INFORMATION !!!

Resihance 40mg is an antineoplastic drug which prohibit with the growth and spread of cancer cells in the body.
Resihance 40mg is needed to treat colorectal cancer and liver cancer. It is also needed to treat a rare type of tumor which can affect the oesophagus, stomach, or intestines.
Resihance 40mg is commonly given after other cancer regimens have been tried without success.
Resihance 40mg is a prescription drugs which is used under the supervision of medical practioners.

INDICATION

Resihance 40mg is indicated for the treatment of metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These contains fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)
- Resihance 40mg is indicated for the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib
- Resihance 40mg is indicated for the treatment of hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

DOSAGE

Colorectal cancer :
The usual dose is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumor :
The usual dose is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.
Hepatocellular carcinoma :
The usual dose is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.
Follow the treatment of this conditions until disease progression or undesirable toxicity

MECHANISM

Regorafenib belongs to oral tumour deactivation agent which potently stops multiple protein kinases, contain kinases included in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). Regorafenib prohibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby stops tumour cell multiplication. In preclinical studies regorafenib has described potent anticancer activity in a broad spectrum of tumour models containing colorectal, gastrointestinal stromal and hepatocellular tumour models which is likely mediated by its anti-angiogenic and anti-proliferative effects. In addition, regorafenib decreased the levels of tumour analogue macrophages and has shown anti-metastatic effects in vivo. Major human metabolites (M-2 and M-5) displayed similar efficacies, compared to regorafenib in in vitro and in vivo models.

ADME

Absorption:
time to peak plasma is 4 hours and concentration is 2.5mcg/mL for single dose; 3.9mcg/mL for steady state and bioavailability is 69-83%
Distribution:
regorafenib has protein bounding about 99.5% and M-2 active metabolite is 99.8%; M-5 active metabolite is 99.95%
Metabolism:
Regorafenib is metabolized by CYP3A4 and UGT1A9
Elimination:
excreted via feces 71%; 19% urine (within 12 days of single dose)
Half-life of
Regorafenib is 28 hr
M-2 active metabolite is 25 hr
M-5 active metabolite is 51hr

PRECAUTION

Myocardial ischemia and infarction seen in clinical trials; withhold Resihance for new or acute cardiac ischemia/infarction and restart only after resolution of acute ischemic events
While treatment with Resihance, one case report of reversible posterior leukoencephalopathy syndrome (RPLS) reported (1 of 1100 treated patients); interrupt therapy if RPLS occurs
serious drug-induced liver injury with fatal outcome appeared in Resihance-treated patients in clinical trials. Some of the cases, liver dysfunction resulted within the first 2 months of treatment and was characterized by a hepatocellular pattern of injury. While treatment with Resihance will Increases risk for haemorrhage; stop therapy for severe or life-threatening haemorrhage
While treatment with Resihance will Increased risk of infections resulted; most common infections contains urinary tract infections, nasopharyngitis, mucocutaneous and systemic fungal infections and pneumonia
While treatment with Resihance will Increases risk for HFSR/PPES and rash; a higher incidence of HFSR resulted in Asian patients; discontinue and then decrease or stop regorafenib depending on severity and persistence of dermatologic toxicity

DRUG INTERACTION

Resihance 40mg concomitant use with strong CYP3A4 inducers will decrease Regorafenib plasma concentrations and increased plasma concentration of active metabolite M-2; M-5.
Resihance 40mg interaction with strong CYP3A4 inhibitor will increase Regorafenib plasma concentration and reduced plasma concentration of active metabolite M-2; M-5.
Resihance 40mg interaction with BCRP substrate will increased the plasma concentration of the BCRP substrate.

MISSED DOSE

If dose is missed, patients must consult with medical practitioner and follow the instructions given by them. Thereby missed dose should be avoid and follow the regular dosing schedule

STORAGE

Store the Resihance 40mg at 25℃ (77℃)
Keep the drug in its original container bottle
Keep the bottle tightly closed after one time used

SIDE EFFECTS

Common side effects occurring in greater than 30% :
Hand-foot syndrome , Diarrhea, Low platelets, Mouth sores/inflammation, Weight loss, Infection, Anemia, Increased liver enzymes (AST, ALT), Fatigue, High blood pressure, Voice disorder (Dysphonia), Protein in the urine, Low calcium, Low phosphorous, Low white blood cells, Decreased appetite, Increased lipase & amylase, High bilirubin in the blood, Low sodium, Nausea.
Less common side effects occurring in about 10-29% of patients receiving Resihance 40mg :
Pain, Fever, Rash, Low potassium, Decreased blood clotting, Increased bleeding, Headache, Alopecia.

We'd Like to Hear From You!

PRESCRIPTION POLICY

1. myapplepharma.com, a fully licensed and regulated pharmacy, takes all precautions to strictly abide by the laws and regulations set forth in the dispensing of prescription medications. By placing the order for your prescription medicines, you acknowledge and accept the following terms regarding the purchase of any prescription medicines.
2. myapplepharma.com will not dispense any prescription medication without a valid prescription from a licensed physician.
3. If you are ordering prescription medication(s), you hereby confirm that you will send us a scanned copy of your valid prescription(s) via email, fax, Whatsapp, or by post, and this prescription shall then be subject to the scrutiny of and approval by our qualified Pharmacists.
4. The drug information provided in the myapplepharma.com is for informative purposes only and this Website is not intended to provide diagnosis, treatment or medical advice. We are not liable for any adverse effects or harm to you as a result of your reliance on the information in the Website.
5. myapplepharma.com requires either the User or Customer or the Caregiver to confirm he/she is completely aware of the indications, side effects, drug interactions, effects of missed dose or overdose of the medicines he/she orders from us. It is imperative to seek professional advice from your physician before purchasing or consuming any medicine from myapplepharma.com.
6. At myapplepharma.com, a Caregiver can order prescription medicines on your behalf.


This information should not be used to decide whether to accept this product or any other medicine. Only a health care provider is knowledge and training to decide that a medicine suitable for a specific patient. This information does not support any drug as safe, are effective or approved for the treatment of any patient or health condition. It's simple a brief overview of general information about this product. It does not include all information on possible applications, indications, warnings, precautions, interactions, adverse effects or risks that may be relevant to this product. This information is not specific medical advice and does not replace information obtained from your health care provider. You should check with your health care provider for complete information about the risks and benefits of using this product.