Lymphoseek - patient leaflet, side effects, dosage

Patient leaflet - Lymphoseek

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

keep this leaflet. you may need to read it again.
if you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
if you get any side effects, talk to your nuclear medicine doctor. this includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Lymphoseek is and what it is used for

This medicine is for diagnostic use in adults only. This means that it is used in breast cancer, melanoma or oral cavity cancers to help find out about your illness. It is not a treatment for your illness.

Before it is used, the powder in the vial which contains tilmanocept is mixed with a radioactive medicine called sodium pertechnetate (containing 99mTc) to make a substance called technetium (99mTc) tilmanocept.

Since technetium (99mTc) tilmanocept contains a small amount of radioactivity it can make parts of the body areas visible to doctors during tests to help them see if the cancer has spread to places called ‘lymph nodes’ that are found near tumours. The lymph nodes nearest the tumour are called ‘sentinel’ lymph nodes. These lymph nodes are where cancer cells are most likely to have spread. When Lymphoseek has found the sentinel lymph nodes, they can be removed and checked to see if there are any cancer cells present. Lymphoseek finds the lymph nodes and can be detected using a special camera or detector.

The use of Lymphoseek does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before Lymphoseek is used

Do not use Lymphoseek

If you are allergic to tilmanocept or any of the other ingredients of this medicine (listed in section 6) or to any of the ingredients of the radiolabelled pharmaceutical.

Warnings and precautions

Talk to your nuclear medicine doctor before you are given Lymphoseek:

if you have experienced any signs of allergic reaction (listed in section 4) after previous admistration of Lymphoseek
if you have kidney or liver problems (renal or heptatic disease)

Children and adolescents

This medicine is not for use in children and adolescents under 18 years of age because it has not been studied in this age group.

Other medicines and Lymphoseek

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.

You must inform the nuclear medicine doctor before the administration of Lymphoseek if there is a possibility you might be pregnant, if you have missed your period, or if you are breast-feeding.

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant, the nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.

If you are breast-feeding, breast milk should be discarded for 24 hours after administration of Lymphoseek. Please ask your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

It is considered unlikely that Lymphoseek will affect your ability to drive or to use machines. Your doctor and nuclear medicine doctor will tell you when it is safe to drive after your surgery.

Lymphoseek contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose. That means it is essentially ‘sodium-free’.

3. How to use Lymphoseek

This medicine is for hospital use only.

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Lymphoseek will only be used in special controlled areas. This product will only be handled and given to you by people who are trained to use it safely. These people will take special care for the safe use of this product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide the quantity of Lymphoseek to be used in your case. It will be the smallest quantity necessary to get the desired information.

The quantity to be administered usually recommended for an adult ranges from 18.5 to 74 MBq (megabecquerel, the unit used to express radioactivity).

The dose may be divided up into smaller amounts. This means that the doctor can make more than one injection in the area around the tumour.

Before administration of Lymphoseek you should:

Follow the instructions of your doctor or nuclear medicine doctor.

Administration of Lymphoseek and conduct of the procedure

Lymphoseek is injected under the skin, under the nipple, or in or around the tumour. The place depends on the type of tumour.

Lymphoseek is given either the day before or on the day of your procedure.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

The nuclear medicine doctor uses a special camera to find Lymphoseek. The surgeon uses the pictures taken to see where the sentinel lymph nodes are located. The surgeon will also use a machine that finds the 99mTc part of the medicine. The 99mTc shows the surgeon where the sentinel lymph nodes are located.

When the sentinel lymph node is found, the surgeon removes it. If there is more than one sentinel lymph node, they will remove these nodes as well. The sentinel lymph nodes are then checked to see if cancer cells have spread to them.

What to do after adminstration of Lymphoseek

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your doctor if you have any questions.

If you have been given more Lymphoseek than you should

An overdose is unlikely because you will get a specially measured amount of Lymphoseek precisely controlled by the doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment.

If you have any further questions on the use of this medicine, ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

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

irritation or pain where the injection is given (including the breast and skin)
wound pain, wound opening or accumulation of fluid at surgical site
feeling sick (nausea) or dizzy
blurred vision
difficulty speaking
headache
increased heart rate
frequent or urgent need to urinate
feeling of warmth, a pricking or tingling sensation, or pain in an extremity, shoulder, the neck or jaw
flushing
high levels of calcium in the blood

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lymphoseek

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only.

Do not use this medicine after the expiry date which is stated on the carton and label after “Exp”. The expiry date refers to the last day of that month.

Do not store above 25°C. Store the vial in the outer carton in order to protect from light.

The radiolabelled solution is stable for 6 hours at a maximum of 25°C.

The radiolabelled product is a clear, colourless solution with no visible particles. Do not use if particulate matter and/or discoloration are seen.

Disposal of radiopharmaceuticals should be done in accordance with national regulation on radioactive materials. These measures will help protect the environment.

6. Contents of the pack and other information

What Lymphoseek contains

the active substance is tilmanocept. each vial contains 50 micrograms of tilmanocept.
the other ingredients are trehalose, dihydrate, glycine (e640), sodium ascorbate (e301), stannous chloride, dihydrate, sodium hydroxide (E524) and hydrochloric acid, dilute (E507).

What Lymphoseek looks like and contents of the pack

Before it is used, the powder in the vial is mixed with another medicine called sodium pertechnetate to make a substance called technetium (99mTc) tilmanocept.

Pack sizes

The glass vials are supplied in a carton containing 1 or 5 vials.

Marketing Authorisation Holder

Navidea Biopharmaceuticals Europe Ltd.

Kilminion South

Ballinroad

Dungarvan

Co. Waterford, X35 WP70

Ireland

Manufacturer

GiPharma S.r.l.

Strada Crescentino snc – 13040

Saluggia (VC)

Italia

Norgine B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

The complete SmPC of Lymphoseek is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please refer to the SmPC [SmPC should be included in the box].