Calogen

Nasal Spray: Postmenopausal osteoporosis in patients for whom alternative treatments are not suitable.

Bone pain associated with osteolysis and/or osteopenia.

Paget's disease of bone (osteitis deformans) only in patients who do not respond to alternative treatments or for whom such treatments are not suitable.

Neurodystrophic disorders (synonymous with algodystrophy or Sudeck's disease), caused by various etiological and predisposing factors eg, posttraumatic painful osteoporosis, reflex dystrophy, shoulder-arm syndrome, causalgia and drug-induced neurotrophic disorders.

Ampoule: Primary osteoporosis eg, early and advanced stages of postmenopausal osteoporosis and senile osteoporosis in women and men; secondary osteoporosis eg, caused by corticosteroid therapy or immobilization.

Bone pain associated with osteolysis and/or osteopenia.

Paget's disease of bone (osteitis deformans) only in patients who do not respond to alternative treatments or for whom such treatments are not suitable.

Hypercalcemia and hypercalcemic crisis due to: Tumoral osteolysis secondary to breast, lung or kidney carcinoma, myeloma and other malignancies. Hyperparathyroidism, immobilisation or vitamin D intoxication. For both the acute treatment of emergencies and the prolonged treatment of chronic hypercalcemia, until specific therapy of the underlying condition proves effective.

Neurodystrophic Disorders (Synonymous with Algodystrophy or Sudeck's Disease): Caused by various etiological and predisposing factors eg, posttraumatic painful osteoporosis, reflex dystrophy, shoulder-arm syndrome, causalgia, drug-induced neurotrophic disorders.

Adjuvant therapy of acute pancreatitis.

Calogen is a man-made form of a hormone that occurs naturally in the thyroid gland.

Calogen nasal is used to treat osteoporosis in women who have been in menopause for at least 5 years.

Calogen nasal may also be used for purposes not listed in this medication guide.

Due to the association between occurrence of malignancies and long-term Calogen use, the treatment duration in all indications should be limited to the shortest period of time possible and using the lowest effective dose.

Injection (Ampoule): Patients should receive precise instruction in the self-administration of SC injections from the physician or the nurse.

Osteoporosis: Recommended Dose: Nasal Spray: 200 IU daily. Ampoule: 50 or 100 IU daily or every 2nd day by SC or IM injection, depending on the severity of the disease.

It is recommended that the use of Calogen be accompanied by adequate intake of calcium and vitamin D to prevent progressive loss of bone mass.

Bone Pain Associated with Osteolysis and/or Osteopenia: Recommended Dose: Nasal Spray: 200-400 IU daily. Up to 200 IU may be administered as a single dose. In cases where a higher dosage is required, it should be given in divided doses.

Ampoule: 100-200 IU daily by slow IV infusion in physiological saline, or by SC or IM injection in divided doses spread over the day, until a satisfactory response is achieved.

Dosage should be adjusted to the individual patient's needs.

It may take several days of treatment until the analgesic effect is fully developed. For continuing therapy, the initial daily dosage can usually be reduced and/or the interval between administrations prolonged.

Paget's Disease: Recommended Dose: Nasal Spray: 200 IU daily in a single dose or in divided doses. In some cases, 400 IU in divided doses may be necessary at the beginning of therapy.

Ampoule: 100 IU daily or every 2nd day by SC or IM injection.

The duration of treatment depends on the therapeutic indication and the patient's response. Dosage should be adjusted to the individual patient's needs.

Treatment markedly reduces serum alkaline phosphatase and urinary hydroxyproline excretion, often to normal levels. However, in rare cases, alkaline phosphatase and hydroxyproline excretion levels may rise after an initial fall; the physician must then judge from the clinical picture whether treatment should be discontinued and when it may be resumed.

Disorders of bone metabolism may recur 1 or several months after treatment has been discontinued, necessitating a new course of Calogen therapy.

Neurodystrophic Disorders: Early diagnosis is essential and treatment should start as soon as the diagnosis is confirmed.

Recommended Dose: Nasal Spray: 200 IU daily in a single dose over a period 2-4 weeks. An additional 200 IU every 2nd day may further be administered for up to 6 weeks depending on clinical progress.

Ampoule: 100 IU daily by SC or IM injection for 2-4 weeks. An additional 100 IU may be given every 2nd day for up to 6 weeks depending on clinical progress.

Hypercalcemia: Emergency Treatment of Hypercalcemic Crisis: Ampoule:

Intravenous infusion is the most effective method of administration and should therefore, be preferred in the treatment of emergencies or other severe conditions.

Recommended Dose: 5-10 IU/kg body weight in 500 mL physiological saline daily by IV infusion over at least 6 hrs, or by slow IV injection in 2-4 divided doses spread over the day.

Treatment of Chronic Hypercalcemic States: Ampoule: Recommended Dose: 5-10 IU/kg body weight daily by SC or IM injection as a single dose or in 2 divided doses. Treatment should be adjusted to the patient's clinical and biochemical response. If the volume of Calogen to be injected exceeds 2 mL, IM administration is preferable and multiple sites of injection should be used.

Acute Pancreatitis: Ampoule: Calogen is a useful adjunct in conservative management, when administered in a dose of 300 IU by IV infusion in physiological saline over a 24-hr period for up to 6 consecutive days.

Development of Antibodies: Antibodies to calcitonins may develop in patients under long-term therapy; clinical efficacy, however, is usually not affected. Escape phenomena, which occur in particular in patients with Paget's disease receiving long-term therapy, may be due to saturation of the binding sites and are apparently not related to the development of antibodies. Following interruption of treatment, the therapeutic response to Calogen is restored.

Administration: Nasal Spray: It is recommended to administer Calogen nasal spray per actuation to alternating nostrils.

Ampoule: The solution in the multi-dose vials can be used for SC or IM, injection or for continuous IV infusion, but is not suitable for IV bolus injection as it contains phenol (5 mg/mL) as a preservative.

See also:
What is the most important information I should know about Calogen?

Hypersensitivity to synthetic salmon Calogen or to any of the excipients of Calogen.

To make sure you are not allergic to Calogen, your doctor may perform an allergy skin test before your first dose of this medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Calogen nasal comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store unopened Calogen nasal in the refrigerator but do not allow it to freeze.

Once you put the bottle and pump assembly together, you may keep the medicine at room temperature, away from light and heat. Store the bottle upright with the pump attached.

Before your first use of the assembled bottle and pump, you must prime the spray. Allow the medicine to reach room temperature before priming.

To prime Calogen nasal, press the pump at least 5 times until a fine mist appears. Prime the spray only before your first use of the newly assembled bottle.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Hold the nasal spray upright with your first and second fingers on each side of the pump and your thumb on the bottom of the bottle.

• Pump the spray unit firmly to spray the medicine into your nostril. You do not need to sniff or inhale deeply.

• Do not blow your nose for at least a few minutes after using the nasal spray.

• If the spray gets in your eyes or mouth or on your skin, rinse with water.

Calogen nasal is usually given as one spray per day into only one of your nostrils. Use the other nostril the next day and continue alternating back and forth for each daily dose.

Calogen nasal spray delivers a fine mist into the nose. Even if you do not feel the spray while using it, the medication is still being absorbed by your nasal passages.

Each bottle contains 30 doses of Calogen nasal. Throw away the medicine after 30 uses, even if there is still medicine left in the bottle.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages often.

Your doctor may have you take extra vitamin D while you are using Calogen nasal. Take only the amount of vitamin D that your doctor has prescribed.

This medication is used to treat brittle bone disease (osteoporosis) in women who are at least 5 years past "the change of life" (menopause). Calogen works by slowing bone loss to help maintain strong bones and reduce your risk of fractures.

This product has been withdrawn from the Canadian market due to safety problems.

How to use Calogen (salmon) nasal

Read the patient and product information sheets if available from your pharmacist before you start using Calogen and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This medication is for use in the nose as directed, usually one spray in one nostril each day, alternating nostrils daily. It is recommended to use this medication at the lowest effective dosage and for the shortest possible duration to treat your condition. Patients treated long-term with this medication have shown a rare risk of developing cancer. Discuss the benefits and risks of long term treatment with this medication.

Remove a new bottle from the refrigerator and allow it to reach room temperature. Follow the instructions on how to prime the pump the first time you use a new bottle. Once the pump is primed, it does not have to be reprimed if the bottle is properly stored in an upright position. Consult your pharmacist if you have any questions.

To use the nasal spray, remove the protective cap, keep your head upright and insert the tip into a nostril. Press down firmly on the pump to deliver the medication. Replace the protective cap. Use the other nostril the next day.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

See also:
What other drugs will affect Calogen?

Nasal Spray: Formal studies designed to evaluate drug interactions with Calogen (salmon) have not been done. No drug interaction studies have been performed with Calogen (salmon) nasal spray ingredients.

Currently, no drug interactions with Calogen (salmon) have been observed. The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Pagets Disease prior diphosphonate use appears to reduce the anti-resorptive response to Calogen (salmon) nasal spray.

See also:
What are the possible side effects of Calogen?

Applies to Calogen: injection injectable, injection solution

Other dosage forms:

• nasal spray

In addition to its needed effects, some unwanted effects may be caused by Calogen (the active ingredient contained in Calogen). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Calogen:

Incidence not known:

• Blurred vision
• chills or fever
• cough
• difficulty with breathing
• difficulty with swallowing
• dizziness
• frequent urination
• headache
• joint pain
• muscle aches and pains
• muscle cramps in the hands, arms, feet, legs, or face
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• skin rash or itching
• slow or fast heartbeat
• sweating
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking of the legs, arms, hands or feet
• trouble sleeping
• unusual tiredness or weakness
• unusual weight gain or loss

Minor Side Effects

Some of the side effects that can occur with Calogen may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Red streaks on the skin
• swelling, tenderness, or pain at the injection site

• Feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest

• Abdominal or stomach pain
• changes in vision
• diarrhea
• pain in the eyes
• poor appetite
• waking to urinate at night

Calogen also contains the following excipients: Nasal Spray: Benzalkonium chloride, sodium chloride, hydrochloric acid (for pH adjustment) and purified water. Ampoule: Acetic acid, sodium acetate trihydrate, sodium chloride and water for injections.

One (1) IU corresponds to 0.2 mcg of synthetic salmon Calogen.

Nasal spray solution in bottles fitted with a metering pump delivering at least 14 doses of 200 IU salmon Calogen per actuation.