Alendronate can cause local irritation of the upper gastrointestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems eg, dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease eg, peptic ulcer or active gastrointestinal bleeding, or surgery of the upper gastrointestinal bleeding or surgery of the upper gastrointestinal tract other than pyloroplasty (see Contraindications).
Oesophageal reactions (sometimes severe and requiring hospitalization) eg, oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophagitis stricture, have been reported in patients receiving alendronate. Physicians should therefore be alert to any signs or symptoms signaling a possible oesophageal reaction, and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation eg, dysphagia, pain or swallowing, or retrosternal pain, new or worsening heartburn. The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronate properly and/or who continue to take it after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to, and understood by the patient (see Dosage & Administration). Patients should be informed that failure to follow these instructions may increase the risk of oesophageal problems. While no increase risk was observed in extensive clinical trials, there have been rare (post-marketing) reports of gastric and duodenal ulcers, severe, bad and with complications. A causal relationship cannot be ruled out.
Osteonecrosis of the jaw generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimen including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (eg, cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Bone, joint and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating (see Adverse Reactions).
The time to onset of symptoms varied from 1 day to several months after starting treatment. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
Patients should be instructed for a missed dose of Maxlen-70. Take 1 tablet on the morning as remembered. Two tablets should not be taken on the same day but should return to taking 1 tablet once weekly, as originally scheduled on the chosen day. Alendronate is not recommended for patients with renal impairment where GFR is <35 mL/min (see Dosage & Administration).
Causes of osteoporosis other than oestrogen deficiency and ageing should be considered. Hypocalcaemia must be corrected before initiating therapy with alendronate (see Contraindications).
Other disorders affecting mineral metabolism (eg, vitamin D deficiency and hypoparathyroidism) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Maxlen-70. Due to positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur. These are usually small and asymptomatic. However, there have been reports of symptomatic hypocalcaemia, which occasionally have been severe and often occurred in patients with predisposing conditions (eg, hypoparathyroidism, vitamin D deficiency and calcium malabsorption). Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids.
Effects on the Ability to Drive or Operate Machinery: No effects on ability to drive and use machines have been observed.
Use in pregnancy & lactation: There are no adequate data for the use of alendronate in pregnant women.
It is not known whether alendronate is excreted into human breast milk. Given the indication, alendronate should not be used by breastfeeding women.