What is Vantavo?
Vantavo is a medicine that contains two active ingredients: alendronic acid and colecalciferol (vitamin D3). The medicine is available as white tablets (capsule-shaped: 70 mg of alendronic acid and 2 800 international units [IU] of cholecalciferol; rectangular in shape: 70 mg of alendronic acid and 5 600 IU of cholecalciferol).
This medicine is similar to Fosavance, already authorized in the European Union (EU). The Fosavance manufacturing company considered that the scientific data relating to it could also be used for Vantavo.
What is Vantavo used for?
Vantavo (containing 2 800 or 5 600 IU cholecalciferol) is treated for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women and at risk of vitamin D insufficiency. Vantavo 70 mg / 5 600 IU is recommended for patients who do not take vitamin D supplements Vantavo reduces the risk of bone fractures in the spine and hip.
The medicine can only be obtained with a prescription.
How is Vantavo used?
The recommended dose is one tablet once a week. The medicine is intended as a long-term therapy.
The tablet should be swallowed with a full glass of water (non-mineral), at least 30 minutes before the ingestion of any food, drink or other medicine (including antacids, calcium supplements and vitamins). To avoid irritating the esophagus (throat), once the medicine has been taken, the patient should not lie down until he has eaten something, which must occur at least 30 minutes after taking the tablet. The tablet should be swallowed whole and should not be crushed, chewed or dissolved in the mouth.
If the normal diet does not ensure sufficient calcium intake, the patient will need to take calcium supplements. For more information, see the package leaflet.
How does Vantavo work?
Osteoporosis occurs when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to fracture. Osteoporosis is more common in women who have passed menopause due to lowering estrogen levels, the hormones that allow healthy bones to be preserved.
Vantavo contains two active ingredients: alendronic acid and colecalciferol (vitamin D3). Alendronic acid is a bisphosphonate, used for the treatment of osteoporosis since the mid-1990s. It blocks the action of osteoclasts, the cells responsible for the destruction of bone tissue. This inhibitory action reduces the loss of bone tissue. Vitamin D3 is a nutrient contained in some foods, but also produced by the skin when exposed to sunlight. Vitamin D3, as well as other forms of vitamin D, is necessary for the absorption of calcium and the normal formation of bone tissue. Since one of the causes of osteoporosis is the insufficient intake of vitamin D3 produced by exposure to sunlight, Vantavo contains this vitamin.
What studies have been carried out on Vantavo?
Since alendronic acid and vitamin D are already used separately in medicines authorized in the EU, the company presented data obtained in previous studies and from published literature by postmenopausal women who took alendronic acid and vitamin D in separate tablets.
To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also conducted studies on 717 osteoporosis patients, including 682 postmenopausal women, to demonstrate Vantavo's ability to increase vitamin D levels. Ai patients were given Vantavo 70 mg / 2 800 IU or alendronic acid only once a week. The main parameter to assess efficacy was the reduction in the number of patients with vitamin D deficiency after 15 weeks. The study was prolonged for 652 patients for 24 weeks in order to compare the effects of a continuous intake of Vantavo 70 mg / 2 800 IU monotherapy or with the addition of 2 800 IU of vitamin D3 (equivalent to the use of Vantavo 70 mg / 5 600 IU).
What benefits has Vantavo shown during the studies?
The information presented by the company derived from previous studies and from the published literature revealed that the dose of alendronic acid contained in Vantavo was the same necessary to prevent bone loss. Further studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels: after 15 weeks, fewer patients had low vitamin D levels when taking Vantavo 70 mg / 2 800 IU (11%) than when taking alendronic acid alone (32%). During the continuation of the study, a similar number of patients taking Vantavo 70 mg / 2 800 IU and Vantavo 70 mg / 5 600 IU had low vitamin D levels, but patients taking Vantavo 70 mg / 5 600 IU presented an increase in vitamin D levels over the 24-week study duration.
What are the risks associated with Vantavo?
The most common side effects with Vantavo (seen in between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (gastric burning), constipation, diarrhea, flatulence (gas), ulcers in the esophagus, dysphagia (difficulty in swallowing), abdominal distension (swollen belly), acid regurgitation and skeletal muscle pain (muscle, bone and joint pain). For the full list of all side effects reported with Vantavo, see the Package Leaflet.
Vantavo should not be used in patients who may be hypersensitive (allergic) to alendronic acid, vitamin D3 or any of the other components. It must not be used in patients who have abnormalities of the esophagus, hypocalcemia (low levels of calcium in the blood) or in patients unable to stand or sit upright for at least 30 minutes.
Why has Vantavo been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Vantavo
On October 16, 2009, the European Commission granted Merck Sharp & Dohme Ltd. a marketing authorization for Alendronate Sodium and Colecalciferol, MSD, valid throughout the European Union. The name of the medicine was changed to Vantavo on March 26, 2010. The marketing authorization is valid for five years, after which it can be renewed.
For the full EPAR of Vantavo, click here. For more information on Vantavo therapy, read the package leaflet (also part of the EPAR).
Last update of this summary: 04-2010.
