Alprostadil Altan 20 micrograms powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprostadil Altan 20 micrograms powder for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Alprostadil Altan is and what it is used for
2. What you need to know before you start using Alprostadil Altan
3. How to use Alprostadil Altan
4. Possible side effects
5. How to store Alprostadil Altan
6. Contents of the pack and other information

1. What Alprostadil Altan is and what it is used for

Alprostadil is a prostaglandin that stimulates blood circulation.

It is used in adults for the treatment of stages III and IV of peripheral occlusive arterial disease (Leriche-Fontaine classification), in patients who are not candidates for revascularization or in whom revascularization has failed, and when lumen-dilating therapy is not possible or has been unsuccessful, excluding patients who are candidates for primary amputation.

Intravenous administration (administration into a vein) is not recommended in stage IV of chronic occlusive disease.

2. What you need to know before using Alprostadil Altan

Do not use Alprostadil Altan

• If you are allergic to alprostadil or to any of the excipients listed in section 6.
• In patients with heart failure causing shortness of breath during everyday activities (New York Heart Association [NYHA] class III) or shortness of breath at rest (NYHA class IV).
• In patients with pre-existing heart damage, such as heart rhythm disorders affecting blood circulation.
• In patients with inadequately treated heart failure.
• In patients with inadequately treated ischemic heart disease.
• In cases of stenosis and/or weakness of the mitral or aortic heart valves.
• If you have had a myocardial infarction or stroke within the last 6 months.
• In patients with severe arterial hypotension.
• In patients suspected of having pulmonary edema or with a history of pulmonary edema associated with heart failure.
• In patients with severe chronic obstructive pulmonary disease (COPD) or disorders involving stenosis of the pulmonary veins (PVOD).
• In patients with dense pulmonary infiltrates, for example due to pneumonia or sarcoidosis.
• In patients with severe renal impairment (oliguria).
• In patients with signs of acute liver injury or known severe liver damage (including history thereof).
• If there is an increased risk of bleeding (e.g., due to multiple trauma).
• In patients with active or potential sites of bleeding, such as acute erosive gastritis, active gastric and/or duodenal ulcer.
• In patients with intracerebral hemorrhage.
• Before, during, and after surgical procedures.
• During pregnancy, lactation, postpartum period, and in women who wish to become pregnant.
• In pediatric populations (children and adolescents).
• If there are general contraindications for infusion therapy (such as heart failure, pulmonary or cerebral edema, or hyperhydration).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Alprostadil Altan.

Intravenous administration is not recommended for chronic occlusive disease in stage IV.

Patients receiving alprostadil must be carefully monitored with each administration. Frequent monitoring of cardiovascular functions is recommended, including blood pressure, heart rate, and fluid balance.

In the following cases, treatment must be carried out under hospitalization and observation maintained for at least 24 hours after administration:

• If you have a predisposition to heart failure or suffer from cardiovascular disease.
• If you have visible edema.
• If you have renal dysfunction (serum creatinine levels above 1.5 mg/dL).

Alprostadil Altan should only be used under specialized medical supervision in the following cases:

• Severe renal impairment.
• Unstable diabetes mellitus.
• Severely compromised cerebral perfusion.
• Thrombocytosis (increased number of blood platelets (platelet count > 400,000/µL)).
• Peripheral neuropathy (damage to peripheral nerves).
• History of cholelithiasis (presence of gallstones).
• History of gastric ulcer.
• Elevated intraocular pressure.
• Epilepsy.

Caution should be exercised in patients with a history of gastrointestinal disorders, including erosive gastritis, gastrointestinal bleeding, gastric and/or duodenal ulcer, as well as history of intracerebral hemorrhage or other types of bleeding (see section 2 “Do not use Alprostadil Altan”).

Caution is recommended in patients receiving concomitant medications that may increase the risk of bleeding, such as anticoagulants or platelet aggregation inhibitors (see section 2 “Other medicines and Alprostadil Altan”). These patients should be closely monitored for signs and symptoms of bleeding.

Alprostadil Altan must not be used in women who may become pregnant.

Alprostadil Altan must not be administered as a bolus injection.

Children and adolescents

Alprostadil Altan is contraindicated in children and adolescents.

Use of Alprostadil Altan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Alprostadil may enhance the effect of the following types of medicines:

• Medicines that lower blood pressure.
• Medicines that inhibit blood coagulation.
• Vasodilator medicines.
• Medicines used in the treatment of coronary artery disease.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Alprostadil Altan is contraindicated in pregnant women, during lactation, and in women who wish to become pregnant.

There are insufficient data on the use of alprostadil during pregnancy or lactation; therefore, its administration is not recommended in these situations.

Furthermore, the safety of alprostadil with regard to fertility has not been established; therefore, its use should be avoided in women of childbearing potential who are not using effective contraceptive methods.

Driving and use of machines

This medicine may lower blood pressure and thus impair reaction capability, even when used according to instructions. This may negatively affect the ability to drive vehicles, operate machinery, or perform tasks requiring a stable base.

Administration with precautions

Patients with a predisposition to develop heart failure or ischemic heart disease, as well as those with peripheral edema or renal insufficiency (creatinine > 1.5 mg/dL), should remain hospitalized under medical supervision during treatment and for 24 hours after its completion.

To prevent symptoms of hyperhydration in these patients, it is recommended that the infused fluid volume does not exceed 50–100 ml per day (using an infusion pump). In addition, frequent and regular cardiovascular monitoring (blood pressure, heart rate) should be performed, including, if necessary, monitoring of fluid balance, central venous pressure, and electrocardiogram.

3. How to use Alprostadil Altan

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Intravenous administration is not recommended in patients with chronic occlusive disease in stage IV.

Alprostadil Altan must be administered exclusively by physicians experienced in the treatment of occlusive peripheral arterial disease, who are familiar with cardiovascular monitoring and have access to appropriate equipment. The physician will determine the dose and route of administration.

Intravenous therapy in stage III:

Based on available clinical experience, intravenous therapy with Alprostadil Altan may be administered according to the following dosage regimen:

Dissolve the contents of 2 vials of Alprostadil Altan (40 µg of alprostadiol) in 50–250 mL of physiological saline solution and infuse intravenously (into a vein) over 2 hours (= 333 ng/min; infusion rate: 0.4–2 mL/min; volumes of 50 mL administered using an infusion pump). This dose is administered intravenously twice daily.

Alternatively, the contents of 3 vials of Alprostadil Altan (60 µg of alprostadiol) may be dissolved in 50–250 mL of physiological saline solution and infused intravenously once daily over 3 hours (= 333 ng/min; infusion rate: 0.3–1.4 mL/min; volumes of 50 mL using an infusion pump).

Dosage in patients with renal impairment

In patients with renal dysfunction (creatinine > 1.5 mg/dL; GFR < 90 mL/min), initiate intravenous treatment with 1 vial of Alprostadil Altan (20 µg of alprostadiol) twice daily for 2 hours. Depending on clinical progress, the dose may be increased after 2–3 days to reach the “standard dose” mentioned above. In patients with renal impairment and in those with cardiac compromise, the infusion volume should be limited to 50–100 mL/day, administered via infusion pump.

Intra-arterial therapy in stages III and IV:

Based on clinical experience, intra-arterial therapy (into an artery) with Alprostadil Altan may follow this regimen: Dissolve the contents of 1 vial of Alprostadil Altan (20 µg of alprostadiol) in 50 mL of physiological saline solution. As initial dose, administer ½ vial of Alprostadil (10 µg) intra-arterially over 60–120 minutes once daily using an infusion pump (= 83–167 ng/min at 0.8 mL/min or 42–83 ng/min at 0.4 mL/min). If necessary and well tolerated, the dose may be increased to 1 vial (20 µg alprostadiol) over the same infusion period (= 333 ng/min at 0.8 mL/min or 167 ng/min at 0.4 mL/min), once daily intra-arterially.

If intra-arterial administration is performed using a permanent catheter, a dose of 0.1–0.6 ng/kg/min over 12 hours via infusion pump is recommended (equivalent to ¼–1½ vials of Alprostadil Altan 20 µg), depending on tolerance and severity of the disease.

Elderly patients

In patients over 65 years of age, treatment should follow the standard dosage regimen.

Patients with hepatic dysfunction

Contraindicated in patients with signs of acute liver injury or known severe liver damage.

Use in pediatric population

Alprostadil Altan must not be used in children or adolescents.

Method of administration

For intravenous (into a vein) or intra-arterial (into an artery) use after reconstitution and dilution with an appropriate solution. The ready-to-use solution must be prepared immediately before administration.

Alprostadil Altan must not be administered by bolus injection.

Duration of treatment

After three weeks of treatment with Alprostadil Altan, the physician must evaluate whether continuing treatment provides clinical benefit. If no therapeutic success is observed, treatment should be discontinued. In any case, the total duration of treatment must not exceed 4 weeks.

If you use more Alprostadil Altan than you should

In case of overdose with Alprostadil Altan, adverse effects related to its vasodilatory action may be intensified, including arterial hypotension and reflex tachycardia (increased heart rate/palpitations).

Other possible symptoms include sudden and brief loss of consciousness, syncope with skin pallor, sweating, nausea and vomiting, myocardial ischemia (insufficient blood supply to the cardiac muscle tissue), and heart failure.

At the local level, symptoms such as pain, edema (fluid accumulation in tissues), and redness along the vein used for infusion may occur.

If signs of overdose occur, the physician will reduce the dose or stop the infusion and decide on additional therapeutic measures (see at the end of this leaflet: Information for healthcare professionals).

If you interrupt treatment with Alprostadil Altan

Consult your doctor before stopping treatment. The decision to discontinue therapy must be evaluated by a healthcare professional.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

If you forget to use Alprostadil Altan

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody experiences them.

The frequency of the possible adverse effects listed below is defined using the following classification:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data.

Common (may affect up to 1 in 10 people):

• Headache.
• Respiratory arrest (apnea).
• Skin redness, localized swelling at the site of administration, transient skin redness (rubefaction reactions).
• Pain.
• After intraarterial administration: sensation of warmth, sensation of swelling, localized edema due to fluid accumulation in tissues, paresthesia (abnormal sensations such as tingling or numbness).

Uncommon (may affect up to 1 in 100 people):

• Transient abnormalities in blood tests, increased C-reactive protein (CRP).
• Dizziness, feeling of weakness, fatigue.
• Fluctuations in blood pressure (especially hypotension), tachycardia, radiating chest pain or discomfort due to ischemic heart disease, palpitations.
• Gastrointestinal disorders (nausea, vomiting, diarrhea, abdominal pain, loss of appetite).
• Allergic reactions (skin hypersensitivity such as rash, pruritus, joint problems, sweating, chills, sensation of warmth, fever).
• Arthralgia (joint pain).
• After intravenous administration: sensation of warmth, sensation of swelling, localized edema at the site of administration or in the infused limb, redness of the infused vein, inflammation of the vein at the injection site, unusual skin sensations (such as tingling or numbness).

These adverse effects are usually reversible and may be alleviated by reducing the dose.

Rare (may affect up to 1 in 1,000 people):

• Changes in white blood cell count, sudden increase or decrease in platelets, with increased risk of bleeding and appearance of bruises.
• Confusional states, cerebral seizures.
• Arrhythmias, bilateral heart failure, development of severe heart failure.
• Acute pulmonary edema (difficulty breathing), bradypnea, increased levels of carbon dioxide in the blood.
• Inflammation of the gastric mucosa, possible obstruction of gastric emptying (pyloric stenosis).
• Changes in liver enzymes, increased transaminases.
• Catheter-tip thrombosis and local bleeding.

Very rare (may affect up to 1 in 10,000 people):

• Partial, reversible thickening of long bones after more than 2–4 weeks of treatment.
• Severe allergic reactions (anaphylactic/anaphylactoid), frequently accompanied by hypotension, dizziness, nausea, and possibly dyspnea.

Frequency not known (cannot be estimated from the available data):

• Stroke.
• Myocardial infarction.
• Dyspnea.
• Gastrointestinal bleeding.
• Bleeding.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprostadil Altan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Store the vials in the outer packaging to protect them from light. Do not store above 25°C.

The reconstituted solution should be prepared immediately before use.

In 0.9% sodium chloride solution, Alprostadil Altan is stable at 2-8°C for 24 hours.

6. Package contents and other information

Composition of Alprostadil Altan

• The active substance is alprostadil 20 micrograms
• The other components are alpha-cyclodextrin and lactose monohydrate

Appearance of the medicine and contents of the pack

White or almost white powder

Alprostadil Altan 20 micrograms, powder for solution for infusion is packaged in boxes containing 1, 28 or 50 (clinical pack) clear type I glass vials with a capacity of 8 ml, fitted with bromobutyl rubber stoppers.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.
C/Colquide, Nº 6, Portal 2, 1st floor, Office F. Edificio Prisma
28231 Las Rozas (Madrid)
Spain

Manufacturer

Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199, P.I. Monte Boyal,
45950 Casarrubios del Monte (Toledo), Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Alprostadil Altan 20μg, Pulver zur Herstellung einer Infusionslösung

Date of the most recent review of this summary: 09/2025

This information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Instructions for use

Physiological saline solution is suitable as a vehicle for intravenous or intraarterial infusion. Compatibility with other infusion solutions or medicinal products has not been investigated.

No other medicinal product should be added to the infusion solution. If concomitant administration of other medicinal products is required, they should be administered through a separate venous access. If this is not possible, compatibility within the infusion system must be ensured beforehand.

The ready-to-use solution should be prepared immediately before administration. Alprostadil Altan infusion solutions must be discarded 12 hours after preparation. The powder dissolves immediately after addition of physiological saline solution. Any initial turbidity of the solution is due to air bubbles and is not clinically significant. A clear solution is obtained within a short time.

The vial contains a white, dry powder forming a solid layer approximately 3 mm thick at the bottom of the vial. This layer may have cracks or be fragmented. If the vial is damaged, the normally dry contents become moist and sticky, losing much of their volume. In such cases, Alprostadil Altan must not be used.

Management in case of overdose

Treatment of overdose symptoms is symptomatic, although it is generally not required due to the rapid metabolism of alprostadil.

In case of overdose or onset of related symptoms, the infusion should be slowed or immediately stopped. In the event of hypotension, the patient should be placed in supine position with legs elevated. If necessary, medications that stabilize blood circulation (e.g., sympathomimetics) may be administered. In case of serious cardiovascular events (such as myocardial ischemia or cardiac failure), the infusion must be immediately discontinued and emergency measures applied. If symptoms persist, cardiac evaluations should be performed and appropriate treatment initiated. If required, the patient must receive urgent medical care.

The patient must not be discharged until cardiovascular stability is achieved.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.