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Farxiga

Farxiga is an oral medication that is prescribed to improve glycemia level in the body of type 2 diabetes patients. Well, Farxiga belongs to a particular class of medications which is called sodium-glucose co-transporter 2 (SGLT2) inhibitors. This medicine should be taken as per the prescription provided by the doctor.

Farxiga must be taken 1 time everyday with or without food. Also, the patient should continue the exercise and the diet as prescribed by the healthcare while consuming Farxiga. Even if you miss a dose, then don’t forget to take it as soon as possible. But if it’s the time for your next dose, then skip the missed one as taking 2 Farxiga in a day is not healthier for anyone. 

Prescription Name and Overview

Farxiga is brand name for dapagliflozin – a drug that is utilized to normalize the level of insulin in your body. Consuming Farxiga therefore makes your lifestyle healthier by reducing the complications. This product was first manufactured by ASTRAZENECA AB and thereafter it received its approval from FDA on 8th January, 2014.

However, during the development of this drug, it has included a wide range of patents. Well, before you start taking this medication, you must tell your doctor about your medical conditions related to kidneys, bladder, liver or pancreas. People, who are suffering from bladder cancer or diabetic ketoacidosis, should not use Farxiga. 

Generic Name and Overview

Dapagliflozin is claimed to be the generic name of Farxiga. This generic version is easily available and affordable as well. It is because the generic manufacturers don’t find it to be costly just like the brand makers do. A survey report says that almost eighteen patents are there to protect this drug.

OTC Name and Overview

Manufacturer

Astrazeneca Pharmaceuticals, LP is considered to be an innovation-driven biopharmaceutical company that mainly focuses on the discovery of new drugs. Well, this company being the manufacturer of Farxiga announced about the approval of this drug back in 2014. Thereafter, the doctors started prescribing this drug 5mg daily to the patients whose names are counted under the type-2 diabetes. 

Moreover, Astrazeneca has reported that Farxiga is one of the mostly sold drugs. And in 2016, this manufacturer has noticed $835 million revenue from this drug. Also, in 2017 a 28% increase in sales has been reported by this company.

Labeled Indications

  • Control high blood sugar for type-2 diabetes patients
  • Prevent kidney damages
  • Cuts down nerve issues
  • Effective in case of loss of limbs
  • Lessens the risk of heart attack
  • Puts an end to sexual functional problems 

Active Ingredients

  • Dapagliflozin Propanediol 10 Mg/1 

Inactive Ingredient(S)

  • Cellulose, Microcrystalline (Unii: Op1r32d61u)
  • Crospovidone (15 Mpa.S At 5%) (Unii: 68401960mk)
  • Cellulose, Microcrystalline (Unii: Op1r32d61u)
  • Silicon Dioxide (Unii: Etj7z6xbu4)
  • Anhydrous Lactose (Unii: 3sy5lh9pmk)
  • Magnesium Stearate (Unii: 70097m6i30)
  • Anhydrous Lactose (Unii: 3sy5lh9pmk)
  • Magnesium Stearate (Unii: 70097m6i30)
  • Crospovidone (15 Mpa.S At 5%) (Unii: 68401960mk)
  • Silicon Dioxide (Unii: Etj7z6xbu4)

What Is It Used For?

Farxiga allows down or stops the production of a particular protein in your body and that is SGLT2. This protein is generally found in kidneys and in presence of which the kidneys start reabsorbing the sugar. Well, once Farxiga stops producing this protein, the kidneys start releasing sugar. And thereafter the excess level of sugar leaves your body through urine.

This drug is available in two strengths and they are 5mg and 10mg. usually, doctors prescribe a dose of 5mg daily to a type-2 diabetes patient. But if that individual needs some additional glycemic control, then the specialists may go for increasing the dose to 10mg. before starting the primary dose, patients must undergo a kidney test to ensure that everything is alright.

Farxiga is yellow in color and it is biconvex, round or diamond-shaped along with film-coated. This tablet with 5mg engraved in one side and in another there is “1427” engraved.

In case of 10mg Farxiga, one side of this tablet is engraved with 10mg whether on the other side you can notice the number “1428”.

How Does it Work?

An individual must take suggestions from the specialists before refilling the medication. Also, you must use this medicine on a regular basis in order to reduce your trouble as soon as possible. However, Farxiga is not recommended for those people who are suffering from moderate to severe kidney problems.

If your body undergoes stress or trauma or if you have developed some infection in your body, then you may need some change in the amount of your diabetes medicine. Always remember if you are asked to take this drug by your doctor, then changing your dose habit without informing your doctor may result in a big trouble. The doctors may ask you to go through blood test for more than once during the treatment is going on.

Follow the instruction of your doctor or healthcare for reducing the high blood sugar level in your body. And if you have some problem with low blood sugar, then talk to the specialist for a better treatment. 

What are the Approved Uses?

Farxiga is marketed by the famous biopharmaceutical house Astrazeneca Ab. This company received the approval in 2014 that includes the permission of NDA. The generic ingredient of this drug is dapagliflozin. It is said that almost twenty-six drug master file entries are made for this particular compound. However, Astrazeneca – the top-most biopharmaceutical firm is operated over 100 countries. The medicine discovered by this brand is utilized and verified by millions of patients from all across the globe. 

Production Anecdotes / History

Farxiga – the invention of AstraZeneca and Bristol-Myers Squibb Company was approved by the FDA. This drug as prescribed by the specialists should be taken as an adjunct to exercise and diet in order to improve the high blood sugar level in the adults.

Well, this approval no doubt carries out some of the limitations. This drug is not appropriate for type-1 diabetes patients. As per the survey, over 24 million of Americans are affected by this disease and amongst them almost 90% are of type-2. This drug has already been approved in more than 40 countries outside the United States. This drug was evaluated in 24 clinical trials which involved 11,000 patients and at the end Farxiga came up with a positive response. 

Precautions

There are certain precautions that a patient must check before using this drug. So, if you are going for a checkup to your specialist, then let the person know about your present condition of health. Tell the doctor if you have any of the following health issues –

  • If you have developed ay liver disease
  • You are running at a high cholesterol level
  • If you maintain a low sodium diet
  • Also, if you ever faced any yeast infection
  • Are you using insulin or you are under some oral diabetes medications
  • If you have ever undergone any kind of surgery including dental one

Apart from these issues, if you are experiencing high level of stress while consuming Farxiga, then you must inform that to your doctor. It helps your specialist to diagnose the disease properly as well as your medicine dose may change according to the present health condition.

Taking Farxiga while you’re Pregnant:

Moreover, if you are pregnant and running on the second or third trimester, then it is highly important to ask your doctor before the specialist prescribe you with Farxiga. Taking this drug during your pregnancy days may not harm the unborn baby but it may create bad effect on the breast milk that you are going to feed the baby. 

Prescribing Farxiga to children under 12 years:

According to WebMD, there is another management precaution for Farxiga. Prescribing this drug to the children under 12years is not safe.

Renal risk may increase:

The research associates of WebMD have opined that if you are an adult over 60, then you may develop renal risk while taking Farxiga. This risk can get higher in case of pre-existing renal impairment issues. According to their research – Cardiovascular-Dapagliflozin usually causes osmotic dieresis. And it may lead your body to developing orthostatic blood pressure changes and falls as well as low intravascular volume.

Also, Farxiga tends to increase the risk of genital mycotic infections. And that’s why patients must be scrutinized before they are prescribed with this drug.

Bladder cancer and Farxiga

Additionally, if your body is not examined properly and prescribed with this drug, then remember that taking Farxiga may lead to bladder cancer. Also, FDA has proved that Farxiga tends to increase the risk of bladder cancer five times more than those patients who usually take old diabetes drugs.

It’s not for type-1 diabetes patients:

This drug should not be assigned to type-1 diabetes patients where patients don’t produce any insulin in their body. In fact, in case of diabetic ketoacidosis Farxiga is not the proper medicine to prescribe. Diabetic ketoacidosis is such a health condition of your body where patient increases the chemical called ketones in their blood.

If you are allergic to the composition:

Are you allergic to dapagliflozin or any other ingredient that is present in Farxiga? Then, you must not take this drug anymore. An allergic person may develop skin rash or raise red patches. Even if you experience these symptoms after taking Farxiga, then immediately stop consuming it.

Long-Term Use Considerations

Dapagliflozin is used to increase sugar removal rate and it keeps your kidney away from any kind of damages. Study suggests that Farxiga should not be prescribed to the patients with an eGFR less than 60 mL/min/1.73 m². This drug must be stored at 20°C to 25°C (68°F to 77°F). Farxiga is a SGLT2 inhibitor which is responsible for reabsorbing the filtered glucose from tubular lumen. However, an increase in LDL-C level may appear while taking this drug. Well, this LDL-C level should be checked and monitored and the patient must be treated as per the standard of care. 

Drug Interactions

According to WebMD – there are few medicines that usually interact with Farxiga or dapagliflozin. Taking these medicines along with Farxiga may create some harmful effects on the patients. Well, the research has established that almost 763 drugs are there that usually interact with Farxiga. Amongst them 1 is major and 704 do moderate interactions and another 58 are noticed to do minor interaction with this drug. So, let’s check the medications as listed below –

Can Interact with the Following

Farxiga may develop serious interaction with –

You can notice a moderate interaction with –

Can’t Interact with the Following

There is no such report released on the non-interaction of any drug with Farxiga. Well, if you are already taking any of the drugs above, then tell the names to your doctor before you start taking Farxiga. Either stop taking those medications or change the medications with another drug. Also, your doctor may suggest you to take both the medications changing its dosage. When two drugs interact together it doesn’t always refer to stop taking any of them. Changing the dosage may also help you to get rid of such factors. 

When To Stop Taking

Don’t stop taking Farxiga without your doctor’s advice. It may cause some adverse effect on your health. However, taking Farxiga can be stopped if you experience some of these following side effects –

  • Lightheadedness while standing or fainting. 
  • Any signs of Ketoacidosis 
  • If you notice some symptoms of developing a serious infection
  • When any signs of serious allergic reactions occur
  • In case of severe Hypoglycemia

Also, you must call your doctor if you become pregnant while you are under the medication of Farxiga as it may harm your breast milk. 

Long-Term Side Effects

There is no report available on long-term side effects of Farxiga.

FDA Warnings (History Of)

From 2013 to 2015, FDA has received the report of almost 101 cases of acute kidney injury. And most of them needed immediate hospitalization along with dialysis. Well, the half of these cases of kidney injury started within 1 month of taking this drug. And the conditions of the patients got improved as soon as they stopped consuming this medicine. FDA has reported that the patients who are going through dehydration or have low blood sugar are often found to take Dapagliflozin which has badly affected their kidneys.

Other Common Side Effects

Farxiga involves some of the common side effects and they are –

  • urinating more than usual
  • diarrhea
  • flu-like illness
  • pain in the arms, legs, hands, or feet
  • genital yeast infection
  • nausea
  • sore throat 
  • back pain
  • stuffy or runny nose
  • constipation

Lawsuits

Type –II diabetes has proved to be one of the biggest health issues for people in the U.S. more than 28 millions of American have suffered from this disease. Though Farxiga has helped most of them in curing this health crisis, thousands of patients have filed lawsuits against the adverse effect of Dapagliflozin. However, in May 2015, FDA has issues a warning regarding this medication. This warning involves the possibility of developing diabetic ketoacidosis.

Patients who have filed some injury lawsuits against this drug have already received compensation awards. Moreover, some experts have expressed their high concern about the SGLT2 inhibitor’s effects on the hearts and bones of the patients. Thereafter, this medication is ordered to conduct a long-term study so that the experts can cut down the risks related to this drug.

Sources Cited (7)

https://www.webmd.com/drugs/2/drug-165641/farxiga-oral/details

https://www.pharmacytimes.com/publications/issue/2014/july2014/farxiga-by-astrazeneca-and-bristol-myers-squibb-company

https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm507785.htm

https://www.medicinenet.com/dapagliflozin/article.htm#what_else_should_i_know_about_dapagliflozin

https://www.healthline.com/health/cdi/farxiga#side-effects

https://www.farxiga.com/taking-farxiga/how-to-take-farxiga.html

https://www.drugdangers.com/farxiga/lawsuit/

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.

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