About Galvus (Vildagliptin)

Galvus (Vildagliptin) is an antidiabetic drug manufactured by the company “NOVARTIS PHARMA, AG” (Switzerland). The medicine is intended for the treatment of type 2 diabetes mellitus in adults. No data are available on the safety of Galvus in children.

Galvus 50 mg

Galvus can be used as monotherapy (in adults inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance) or in combination with other pharmaceutical products (such as metformin, sulfonylurea or thiazolidinedione). A triple therapy (vildagliptin + sulfonylurea + metformin) is permissible. Galvus is also indicated for use in combination with insulin when diet, exercise and a stable dose of insulin don’t provide a desired therapeutic effect.

Exenatide

Composition And Active Ingredients

Galvus is an antidiabetic drug that contains the active substance vildagliptin. The drug also contains such inactive ingredients as microcrystalline cellulose, lactose anhydrous, sodium carboxymethyl starch and magnesium stearate. Galvus is available in the form of 50 mg tablets.

Do I Need A Prescription

Galvus is subject to medical prescription. Patients be monitored closely during the treatment. When prescribing Galvus, the doctor must provide the patients with the information on the safe and efficient use of this drug.

Galvus Dosage

To ensure the effectiveness and safety of treatment with Galvus, always follow the dosage prescribed by your doctor. The health specialist determines the drug dosage individually for each patient taking into account the severity of diabetes and the presence of risk factors (such as liver or kidney failure, old age or alcohol abuse).

How To Take Vildagliptin

You must take Galvus during meals strictly according to the doctor’s recommendations. The recommended dose for adults is:

  • 1 pill in the morning and evening (50+50 mg per day) in monotherapy or in combination with metformin, thiazolidinedione, metformin + sulfonylurea/insulin;
  • 1 pill in the morning (50 mg per day) in combination with sulfonylurea (to reduce the risk of hypoglycemia).

Never exceed the maximum recommended dosage, as it can cause a number of side effects and negatively affect your health.

Maximum Dose

The daily dose of the drug shouldn’t exceed 100 mg (2 pills). In patients with renal diseases, the recommended dose of Galvus is 50 mg once daily. The same doses are prescribed to the patients with type 2 diabetes.

Table 1.

Key efficiacy results of vildagliptin in placebo-controlled monotherapy trials and in add-on combination therapy trials (primary efficacy ITT population).

 Monotherapy placebo controlled studies  Mean baseline HbA 1c (%)  Mean change from baseline in HbA 1c (%) at week 24  Placebo-corrected mean change in HbA 1c (%) at week 24 (95% Cl)
 Study 2301: Vildagliptin 50 mg once daily (N=104)  8.2  -0.8  -0.5* (-0.8, -0.1)
 Study 2301: Vildagliptin 50 mg twice daily (N=90)  8.6  -0.8  -0.5* (-0.8, -0.1)
 Study 2384: Vildagliptin 50 mg once daily (N=84)  8.3  -0.5  -0.5* (-0.9, -0.1)
 Study 2384: Vildagliptin 50 mg twice daily (N=79)  8.4  – 0.7  -0.7* (-1.1, -0.4)
     * p<0.05 for comparison versus placebo  
 Add-on/Combination studies      
 Study 2303: Vildagliptin 50 mg once daily+metformin (N=143)  8.4  -0.5  -0.7* (-1.0, -0.5)
 Study 2303: Vildagliptin 50 mg twice daily+metformin (N=143)  8.4  -0.9   -1.1* (-1.4, -0.8)
 Study 2305: Vildagliptin 50 mg daily+glimepiride (N=132)  8.5  -0.6  -0.6* (-0.9, -0.4)
 Study 2304: Vildagliptin 50 mg daily+pioglitazone (N=124)  8.6  -0.8  -0.5 (-0.7, -0.2)
 Study 2304: Vildagliptin 50 mg twice daily+pioglitazone (N=136)  8.7  -1.0  -0.7* (-0.9, -0.4)
 Study 2311: Vildagliptin 50 mg twice daily+insulin (N=125)  8.5  -0.5  -0.3* (-0.5, -0.0)
 Study 23135: Vildagliptin 50 mg twice daily+insulin  8.8  -0.8  -0.7* (-0.9, -0.5)
 Study 23152: Vildagliptin 50 mg twice daily+metformin+glimepiride (N=152)  8.8  -1.0  -0.8* (-1.0, -0.5)
     * p<0.05 for comparison versus placebo+background therapy  

What If I Miss A Dose

If you miss a dose of Galvus, don’t take a double dose to make up for a forgotten pill. Take the missed dose as soon as you remember. However, if it’s almost time for your next dose, skip the dose you missed and take your next dose at the usual time.

Overdose

Information regarding overdose with vildagliptin is limited. Therefore, we will focus on a study in patients given Galvus for 10 days. According to the results of these studies, 400 mg of Galvus caused muscle pain, mild and transient paraesthesia, fever, edema and a transient increase in lipase levels in some patients. At 600 mg, one patient experienced edema of the feet and hands, as well as increases in:

  • creatine phosphokinase;
  • aspartate aminotransferase;
  • C-reactive protein;
  • myoglobin.

After discontinuation of the drug, all the above-mentioned symptoms disappeared without medical intervention.
In case of an overdose, supportive care is recommended. Vildagliptin can’t be removed by hemodialysis. Therefore, you should carefully monitor the drug dosage. In case of overdose, contact your doctor immediately and follow his/her instructions.

Interaction With Other Products

As any other drug, Galvus (Vildagliptin) may interact with other drugs and substances. More information on this is given below.

Alcohol/food Interactions

It is strongly recommended to reduce alcohol consumption while taking Galvus (Vildagliptin). Excessive drinking can cause extremely low blood sugar levels, which will make you feel worse (and in extreme cases- cause serious health problems). Other side effects are also possible. Therefore, patients with type 2 diabetes who take vildagliptin must not abuse alcohol.

Other Medicines

Vildagliptin has a low potential for interactions with co-administered medicinal products. Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and doesn’t inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.

Results from studies conducted with pioglitazone, metformin and glyburide have shown no clinically relevant pharmacokinetic interactions. Clinical studies performed with healthy volunteers taking Galvus in combination with digoxin and warfarin have shown no clinically relevant pharmacokinetic interactions. Drug-drug interaction studies in healthy volunteers were conducted with amlodipine, ramipril, valsartan and simvastatin.

In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin. Combined use of vildagliptin and an ACE inhibitor increases the risk of angioedema. You also need to consider that a number of active substances such as corticosteroids, thyroid drugs, thiazides and sympathomimetics, reduce the glucose-lowering effect of vildagliptin. Therefore, any mixing of pharmaceuticals must be performed under the strict supervision of a certified physician.

What Side Effects Are Reported With Galvus?

Like all medicines, Galvus can cause side effects, although not everybody gets them. Practice shows that some side effects go away over time as the patient’s body gets used to a new drug.

Note: Always carry some form of sugar you can eat during the treatment. If you have symptoms of hypoglycemia (cold sweat, cold pale skin, tremor and anxiety), you need to eat something sweet or drink fruit juice to stabilize your blood sugar.

Table 2

Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)

 Metabolism and nutrition disorders
 Common  Hypoglycaemia
 Nervous system disorders
 Common  Tremor, dizziness, headache
 Uncommon  Fatigue
 Gastrointestinal disorders
 Common  Nausea

Common Side Effects

The most common side effects of Galvus are:

  • Nausea
  • Dizziness
  • Headache
  • Back pain

These symptoms are typical for the active ingredient of Galvus. If you feel much worse after taking the drug, you should see your doctor immediately.

Serious Side Effects

The use of Galvus can cause symptoms of liver (abdominal pain, yellow eyes and skin, itching, dark urine and pale stool) or pancreas (prolonged abdominal pain) diseases. In rare cases, patients may experience constipation or swollen hands/feet. Other side effects not listed in this leaflet are also possible. In all these cases, you need to contact your doctor and follow his/her instructions.

Galvus (Vildagliptin) Tablet Alternatives

At the moment, Vildagliptin is available in the pharmaceutical market under the following names:

  • Vildazem 50mg
  • Zukanorm 50mg
  • Gliptagreat 50
  • Vildanat
  • Vinsorin,
  • etc.

A doctor may choose one of the above-mentioned generics as an alternative to Galvus (Vildagliptin) at his/her own risk. There are also other generics of this drug- both single component and multicomponent.