Prialt 100 micrograms/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Prialt 100 micrograms/ml solution for infusion

Ziconotide

Read this entire leaflet carefully before you are given the 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 or pharmacist.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

.

Leaflet contents:

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

1. What Prialt is and what it is used for

Prialt contains the active substance ziconotide, which belongs to a group of medicines called analgesics or "pain medicines". Prialt is used for the treatment of severe chronic pain in adults who require a pain medicine administered by intrathecal injection (injection into the space surrounding the spinal cord and brain).

2. What you need to know before you are given Prialt

Do not administer Prialt

• If you are allergic to ziconotide or to any of the other components of this medicine (listed in section 6).
• If you are being administered an anticancer medicine into the area surrounding the spinal cord.
• If you have a history of suicide attempt or suicidal ideation with ziconotide.

Warnings and precautions

Patients must undergo a neuropsychiatric evaluation before, after initiation of, and during intrathecal ziconotide administration, and immediately whenever any depressive signs or symptoms occur.

Caregivers should contact a doctor immediately if the patient experiences symptoms of a potentially life-threatening adverse event.

Talk to your doctor before you are given Prialt.

• The effects of long-term treatment with Prialt are, to date, uncertain, and the possibility of toxic effects on the spinal cord has not yet been ruled out. If long-term treatment is required, monitoring may be necessary (as decided by your doctor).
• If you are receiving Prialt via a pump placed outside the body, it is important that you check once daily for signs of infection at the site where the catheter enters the body.
• If you notice any signs of infection around the catheter, such as redness of the skin, swelling, pain, or discharge, you must inform your doctor immediately and seek treatment for the infection.
• If you experience increased sensitivity in the area around the catheter but there are no signs of infection, you should consult your doctor as soon as possible, as this may be an early sign of infection.
• If you are receiving Prialt with a pump placed outside the body and any part of the infusion system becomes disconnected, you must contact your doctor or nurse immediately.
• If you experience any of the following symptoms: high temperature, headache, neck stiffness, fatigue, confusion, malaise, vomiting, or occasional seizures, these may be signs of meningitis. If you experience any of the above symptoms, you must inform your doctor immediately.
• If you experience any changes in your thoughts, mood, or memory, consult your doctor.
• If you are receiving chemotherapy, inform your doctor.
• You may have an increase in blood levels of an enzyme called creatine kinase; although this usually does not cause any symptoms or problems, your doctor will likely monitor this. In addition, you may occasionally experience muscle problems. If so, you must report this to your doctor immediately, as they may decide to discontinue treatment with Prialt.
• Inform your doctor immediately if you experience any of the following symptoms: sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face, or lips, rash, or itching (especially if affecting the whole body). These may be signs of a severe allergic reaction.
• In patients with severe chronic pain, there is a higher risk of suicide and suicide attempts than in the general population. Prialt may also cause or worsen depression in individuals who are already susceptible. If you have depression or a history of depression, inform your healthcare professional before starting Prialt. If, after starting treatment with Prialt, you experience worsening depression or any other symptoms affecting your mood, inform your healthcare professional.
• You may experience drowsiness or reduced awareness of your surroundings during treatment. If this occurs, you must inform your doctor immediately, as they may decide to discontinue treatment with Prialt.

Children and adolescents

Prialt is not recommended for use in children and adolescents.

Other medicines and Prialt

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines (for example, baclofen, used to treat muscle spasticity; clonidine, used to treat high blood pressure; bupivacaine, used for local anesthesia; morphine, used for pain; propofol, used for general anesthesia; or any other medicine administered by intrathecal injection [injection into the space surrounding the spinal cord and brain]). You may experience drowsiness if you use Prialt together with certain medicines used to treat pain.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Prialt is not recommended during pregnancy or in women of childbearing potential who are not using contraceptive methods.

Driving and using machines

It has been reported that the use of Prialt may cause confusion and drowsiness. Consult your doctor before driving or operating machinery.

Prialt contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per maximum recommended intrathecal dose (21.6 micrograms per day); thus, it is essentially “sodium-free”.

3. How to use Prialt

Treatment with Prialt must be managed by a physician experienced in the administration of drugs into the area surrounding the spinal cord and in the use of internal and external infusion pumps.

The recommended starting dose is no more than 2.4 micrograms per day. Your doctor may very slowly adjust the dose of Prialt, depending on the intensity of your pain, by increasing it by no more than 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the beginning of treatment, your doctor may increase the dose every one or two days, or less frequently. If side effects become too severe, the dose may be reduced or the infusion stopped.

Prialt is administered by continuous, very slow injection into the space surrounding the spinal cord (intrathecal route). The medicine will be delivered continuously via a pump that may either be implanted in the abdominal wall or placed externally and worn with a belt. Your doctor will discuss with you which type of pump is most suitable for you and will inform you when the pump needs to be refilled.

Pain relief may be achieved gradually by very slowly adjusting the dose of Prialt. If you feel that your pain is still too severe despite treatment with Prialt, or if side effects are too bothersome, inform your doctor.

Before starting Prialt, your doctor may decide to gradually discontinue opioids (other types of pain medications) administered into the spinal cord and replace them with alternative analgesic medications.

If you receive more Prialt than you should

If you receive more Prialt than intended by your doctor, you may experience symptoms such as confusion, speech problems, difficulty finding words, excessive agitation, dizziness, excessive drowsiness, and a general feeling of being unwell. If you experience any of these symptoms, contact your doctor or go to the hospital immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

You must inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment.

• Meningitis (may affect up to 1 in 100 people): inflammation of the membranes surrounding the brain and spinal cord, usually caused by infection. Symptoms of meningitis include headache, neck stiffness, sensitivity to bright light, fever, vomiting, confusion, and drowsiness.

• Seizures (may affect up to 1 in 100 people): seizures (epileptic fits) are sudden, uncontrollable body movements. During a seizure, a person's muscles contract and relax repeatedly, and the person may lose consciousness.

• Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people).

• Rhabdomyolysis (may affect up to 1 in 100 people): breakdown of muscle fibers that may lead to kidney damage. Symptoms of rhabdomyolysis include abnormally colored urine (brown), reduced urine output, muscle weakness, muscle pain, or tenderness upon palpation.

• Coma (may affect up to 1 in 100 people): a state of unconsciousness with difficulty responding or waking up.

• Anaphylactic reaction (frequency cannot be estimated from available data): a severe allergic reaction. Symptoms include sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face, and lips, skin rash, or itching (especially if affecting the whole body).

Other adverse effects

Very common (may affect more than 1 in 10 people)

Confusion, dizziness, blurred vision, headache, rapid eye movements from side to side, loss or disturbances of memory (forgetfulness), vomiting, nausea, general weakness, and drowsiness.

Common (may affect up to 1 in 10 people)

Decreased appetite, anxiety or worsening of anxiety, hallucinations, difficulty falling asleep or staying asleep, restlessness, disorientation, depression or worsening of depression, nervousness, mood changes, mental disorders (abnormal thinking, confusion), paranoia, irritability, worsening of confusion, difficulties with learning, memory, or thinking, absence or impairment of reflexes, problems expressing or understanding words, stammering, difficulties with speech or loss of ability to speak, lethargy, disturbances in balance or coordination, burning sensation, increased abnormal sensations, decreased level of consciousness (not responding or nearly unconscious), sedation, difficulty concentrating, problems with sense of smell, altered or absent taste, agitation, tingling, double vision, visual disturbances, light intolerance, tinnitus (ringing in the ears), dizziness, or sensation of spinning, faintness or dizziness upon standing, hypotension, difficulty breathing, dry mouth, abdominal pain, increased nausea, diarrhea, constipation, sweating, pruritus, muscle weakness, muscle spasms, muscle cramps, muscle or joint pain, difficulty or pain when urinating, difficulty initiating or controlling urination, restlessness, falls, pain or increased pain, fatigue, feeling cold, swelling of the face, legs, or feet, chest pain, blood chemistry abnormalities, mental deterioration, and weight loss.

Uncommon (may affect up to 1 in 100 people)

Bloodstream infection, delirium (mental confusion), psychotic disorder (abnormal thoughts and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, stupor (no response/difficulty waking), stroke, encephalopathy (brain disorder), aggression, abnormal heart rhythm, difficulty breathing, indigestion, skin rash, muscle inflammation, back pain, muscle spasms, neck pain, acute kidney failure, abnormal findings on electrocardiogram (ECG), increased body temperature, and difficulty walking.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prialt

Keep this medicine out of sight and reach of children.

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

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep the vial in the outer packaging to protect it from light.

Chemical and physical in-use stability has been demonstrated for 60 days at 37°C.

From a microbiological standpoint, once diluted, the product should be transferred immediately to the infusion pump. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should generally not exceed 24 hours between 2°C and 8°C, unless dilution has been carried out under validated and controlled aseptic conditions.

Do not use this medicine if you notice any change in colour, cloudiness, or particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prialt

• The active substance is ziconotide.
• One ml of solution contains 100 micrograms of ziconotide (as acetate).
• Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml vial contains 500 micrograms.
• The other components (excipients) are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the pack

Prialt is a solution for infusion (infusion). The solution is clear and colourless. Prialt is available in packs containing a single vial of 1 ml, 2 ml or 5 ml. Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151

14199 Berlin

Germany

Manufacturer responsible:

HWI pharma services GmbH

Straßburger Straße 77

77767 Appenweier

Germany

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: {MM/YYYY}

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also available.

This information is intended for healthcare professionals only:

Instructions for use and handling

Prialt is supplied as a clear, colourless solution in single-use vials. Before administration, the solution should be visually inspected for the presence of particles and for any discoloration. The solution must not be used if it has changed colour, appears cloudy, or if particulate matter is observed.

For single use only. Any unused medicinal product and all materials that have come into contact with it must be disposed of in accordance with local regulations.

If dilution is required, Prialt must be diluted aseptically immediately before use with sodium chloride 9 mg/ml (0.9%) injection solution, without preservatives. The concentration of the solution used in the infusion pump must not be less than 5 μg/ml of ziconotide in an external pump and 25 μg/ml in an implanted pump.

Strict aseptic procedures must be followed during the preparation and handling of the infusion solution and when filling the pump. Both the patient and healthcare personnel must be familiar with the handling of external or implanted infusion systems and must understand the importance of preventing infections.

Specific instructions for use provided by the pump manufacturers must be followed.

Prialt has been shown to be chemically and physically compatible with the Synchromed implantable pump and the CADD-Micro external pump at the concentrations stated above. Chemical and physical stability has been demonstrated for up to 14 days at 37°C in the Synchromed pump when the pump has not previously been in contact with the medicinal product. Therefore, the initial fill must be replaced after 14 days.

Prialt was stable for 60 days at 37°C in the Synchromed pump previously exposed to the medicinal product. Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.

Technical data are provided for informational purposes only and should not restrict healthcare professionals' choice. For the administration of ziconotide, infusion pumps bearing the CE mark and equivalent to the Synchromed and CADD-Micro pumps should be used.

Pumps previously used for other medicinal products must be flushed three times with 9 mg/ml (0.9%) sodium chloride injection solution (without dyes) before being filled with ziconotide. The amount of air introduced into the pump reservoir or cartridge must be minimized, as oxygen may degrade ziconotide.

Before starting treatment, implanted pumps must be flushed three times with 2 ml of solution at a concentration of 25 μg/ml. The concentration of Prialt in a new pump may decrease due to absorption onto device surfaces or dilution by residual volume within the device. For this reason, after first use of Prialt, the reservoir must be emptied and refilled after 14 days. Subsequently, the empty pump reservoir must be refilled every 60 days.