One-Alpha (Cheplapharm Arzneimittel): Uses, Side Effects and Dosage

What is ONE-ALPHA used for?

ONE-ALPHA is used in adult patients with chronic kidney failure to treat:

• Low calcium levels in the body (hypocalcaemia)
• Bone disease (osteodystrophy)
• A condition in which the parathyroid gland is overactive (hyperparathoidism)

How does ONE-ALPHA work?

ONE-ALPHA contains the medicinal ingredient alfacalcidol, which works similarly to vitamin D. Alfacalcidol helps your body absorb calcium from your diet.

What are the ingredients in ONE-ALPHA?

Medicinal ingredients: alfacalcidol

Nonmedicinal ingredients:

ONE-ALPHA Capsules:

• 0.25 mcg: all-rac-α-tocopherol and sesame oil; shell composition: gelatin, glycerol, potassium sorbate, titanium dioxide, medium chain triglyceride, Phosal 53 MCT.
• 1 mcg: all-rac-α-tocopherol and sesame oil; shell composition: gelatin, glycerol, potassium sorbate, titanium dioxide, red iron oxide E172, and black iron oxide E172, medium chain triglyceride, Phosal 53 MCT.

ONE-ALPHA Oral Drops:

• all-rac-α-tocopherol, citric acid monohydrate, ethanol, macrogolglycerol hydroxystearate, methylparahydroxybenzoate, purified water, sodium citrate, and sorbitol

ONE-ALPHA Injection:

• citric acid monohydrate, ethanol, propylene glycol, sodium citrate, and water

ONE-ALPHA comes in the following dosage forms:

ONE-ALPHA Capsules:

• 0.25 mcg – cream-coloured, egg-shaped capsule
• 1 mcg – brown, egg-shaped capsule

ONE-ALPHA Oral drops:

• 2 mcg / mL (10 mL and 20 mL bottles) – clear or slightly opalescent colourless solution

ONE-ALPHA Injection:

• 2 mcg / mL (each ampoule contains 1 mcg / 0.5 mL or 2 mcg / 1 mL) – clear colourless solution for intravenous injection

Do not use ONE-ALPHA if:

• you are allergic to any of the ingredients in ONE-ALPHA or the packaging
• you have high calcium levels in your blood (hypercalcemia)
• you know you have high phosphate levels in your blood (hyperphosphatemia)
• you took a dose of Vitamin D and overdosed

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ONE-ALPHA. Talk about any health conditions or problems you may have, including if you:

• have arteries or heart valves that are hardened and stiff (arteriosclerosis or cardiac valve sclerosis)
• are taking heart medicines called a cardiac glycoside, such as digoxin
• are taking other vitamin D medicines or similar products
• have any kidney problems, including kidney stones
• are on dialysis treatment
• have an immune system or inflammatory disease like sarcoidosis
• are suffering from alcoholism and have liver disease or epilepsy. ONE-ALPHA solution for injection and oral drops contain alcohol

Other warnings you should know about:

• High calcium and phosphorus levels: Treatment with ONE-ALPHA can cause high calcium levels in your blood (hypercalcemia) and urine (hypercalciuria). This depends on your bone building process, how well your kidneys work, and the dose of ONE-ALPHA. High calcium levels caused by ONE-ALPHA can cause:

  • Heart problems like hard and stiff arteries or heart valves, abnormal heart beats for patients taking medicines for heart problems and heart disease in patients with lung calcium deposits.
  • Calcium deposits (calcification) on your arteries and veins, kidneys or eyes.
  • Kidney problems.

ONE-ALPHA can also cause high phosphorus levels in your blood. Your healthcare professional might put you on a low phosphate diet and have you take other medicines to control phosphate levels. They will do blood and urine tests while you are taking ONE-ALPHA. These tests will tell your healthcare professional how your calcium and phosphate levels are.

Check-ups and testing: You will have regular visits with your healthcare professional during your treatment. They might do:

• Blood and urine tests. This will check for different levels of proteins, cholesterol, liver enzymes and other substances.
• Eye exams to check your eyes for calcium deposits.
• Diagnostic imaging like x-rays and ultrasounds to check for calcium deposits in different parts of your body.

Pregnancy and breastfeeding:

Female patients

• If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
• You should not take ONE-ALPHA if you are pregnant. It may harm your unborn baby.
• You should not take ONE-ALPHA if you are breastfeeding. ONE-ALPHA may be present in breast milk.

Pediatrics (children less than 18 years old): ONE-ALPHA should not be used in children less than 18 years old.

Geriatrics (adults 65 years and older): ONE-ALPHA should not be used in geriatric patients.

Tell your healthcare professional about all the medicines you are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ONE-ALPHA:

• medicines to treat seizures (anticonvulsants) like barbiturates, phenytoin, carbamazepine or primidone
• medicines called barbiturates that help you sleep
• medicines used to treat heart problems (cardiac glycosides) such as digoxin
• medicines used to treat high blood pressure like thiazide diuretics
• medicines that help your body get rid of water ("water pills" or diuretics)
• medicines such as cholestyramine, used to lower cholesterol levels, or to help stop some types of diarrhea or itching
• medicines for heartburn (antacids) and stomach ulcers that contain magnesium or aluminum hydroxide or sucralfate
• mineral oil used as a laxative
• medicines that contain calcium
• medicines that contain vitamin D or related ingredient (you should not take these medicines while you are taking ONE-ALPHA)

How to take ONE-ALPHA:

• Take ONE-ALPHA Capsules whole.

• Take with or without food, and or drink.

• Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Do not stop taking ONE-ALPHA without first checking with your healthcare professional.
• Your healthcare professional will send you for blood tests to see if your dose needs to be changed or stopped. They may also have you take other medicines and a special diet to help improve your health.

Usual dose:

ONE-ALPHA Capsules and Oral Drops:

• Your healthcare professional will decide your dose of ONE-ALPHA based on your health.
• ONE-ALPHA is usually taken once daily.
• When using the ONE-ALPHA Oral Drops, remove the protective cap but not the plastic dropper which is inserted into the bottle. To use the dropper, hold the bottle in a vertical position, upside down. The liquid should flow right away, but if it does not, tap the bottle gently. Do not shake the bottle.

ONE-ALPHA Injection:

• Your healthcare professional will give you ONE-ALPHA Injection. You will get the injection during hemodialysis and only if you have chronic kidney failure.

Overdose:

• If overdose is discovered within a short time: Your healthcare professional will have you vomit or pump your stomach. This will prevent more absorption by your stomach.
• If the medicine has passed through your stomach, your healthcare professional might give you mineral oil. This will help remove the medicine by a bowel movement.
• Your healthcare professional might stop your doses of extra calcium and put you on a low calcium diet if you have an overdose.

Missed dose:

If a dose is forgotten, take it as soon as possible. If it is almost time for the next dose, do not double the dose.

What are possible side effects from using ONE-ALPHA?

These are not all the possible side effects you may have when taking ONE-ALPHA. If you experience any side effects not listed here, tell your healthcare professional.

• nausea, vomiting
• constipation
• diarrhea
• loss of appetite
• weight loss
• abdominal pain
• dry mouth
• feeling weak, sleepy, dizzy
• itching, rash
• headache
• sweating
• runny nose
• lower sex drive
• feeling hot

ONE-ALPHA can cause abnormal blood and / or urine tests. Your healthcare professional will decide when to perform these tests and will interpret the results. These tests will tell your healthcare professional how ONE-ALPHA is affecting your blood, heart, liver, pancreas, kidneys, and muscles.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• ONE-ALPHA Capsules: Store below 25°C. Protect from direct sunlight.
• ONE-ALPHA Oral Drops: Store in your refrigerator (2-8°C). Protect from direct sunlight. Use within 4 months of first opening the bottle.
• ONE-ALPHA Intravenous Ampoules: Store in outer carton in the refrigerator (2-8°C). Protect from direct sunlight. Shake well before use. Ampoule is for single use only – throw away unused portion.

Keep out of reach and sight of children. ONE-ALPHA contains enough medication to seriously harm a child.

Do not use ONE-ALPHA after the expiry date indicated on the label.

If you want more information about ONE-ALPHA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html)

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489, Greifswald

Germany

Last Revised: FEB 02, 2026