Drugs List

Therapeutic Indications

Uses

Palliative treatment of patients with advanced head and neck squamous cell carcinoma not responsive to previous treatment and unsuitable for radiotherapy, surgery or systemic chemotherapy.

Administration

Temoporfin is administered via an indwelling intravenous cannula in a large proximal limb vein, preferably in the antecubital fossa, as a single, slow intravenous injection over not less than 6 minutes. The patency of the indwelling cannula should be tested before injection and every precaution taken against extravasation.

An in-line filter must be used as a precautionary measure and is provided in the package with the injection. Do NOT flush with sodium chloride solution or any other aqueous solution.

Transient injection site pain can be reduced by slowing the injection rate.

Contraindications

Porphyria or other diseases exacerbated by light
Known allergies to porphyrins
Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
A planned surgical procedure within the next 30 days
Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days
Pregnancy
Breastfeeding
Children under 18 years

Precautions and Warnings

Temoporfin photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy.

Take special care to prevent extravasation at the injection site. If extravasation occurs, protect the area from light for at least 3 months. There is no known benefit from injecting the extravasation site with another substance.

Some pulse oximeters may product light of a wavelength close to that used for the photo activation of temoporfin. Oximeters must be repositioned at least every 10 to 15 minutes to avoid the risk of local skin burns.

Unplanned or emergency surgical procedure within 30 days of administration of temoporfin must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient. All precautions must be taken to avoid direct illumination of the patient with surgical lamps during these procedures.

Women of child-bearing age must use effective contraception for 3 months after treatment with temoporfin.

All patients who receive temoporfin will become temporarily photosensitive. During the first 15 days after injection precautions must be taken to avoid exposure of the skin or eyes to direct sunlight or bright indoor light.

Skin photosensitivity reactions are caused by visible light, therefore ultraviolet sunscreens do not
provide protection. It is important that patients are re-introduced to normal light gradually.

Clinicians must counsel patients to observe the necessary precautions (see below) and provide them with a copy of the patient information leaflet.

Prevention of photosensitivity reactions/burns

Day 1 (0 - 24 hours after injection) Stay indoors in a darkened room. Keep the curtain drawn and use light bulbs of 60W or less. Avoid exposure to direct sunlight.

Days 2 - 7 Gradually return to normal indoor lighting. Avoid direct sunlight coming through the window or direct light from household appliances, such as reading lamps. You may watch television and go outdoors after dusk.

If it is essential to go outdoors during daylight hours, cover up all skin including face and hands and wear dark glasses. Appropriate clothing is dark and closely woven (thin clothing will not provide adequate protection against strong light). Wear the following:
Wide-brimmed hat for head, neck, nose and ears,
Scarf for head and neck
Sunglasses with side-panels for eyes and surrounding skin,
Long-sleeved top for upper body/arms,
Long trousers for lower body/legs,
Gloves for hands, wrist and fingers,
Socks and closed shoes for feet and ankles.

If you are exposed to light by mistake, you may get a prickly or burning feeling on the skin. You must get out of the light immediately.
Your eyes may be very sensitive to bright lights during this week. If you get eye pain or headache when lights are switched on, wear dark glasses.

Days 8 - 14 Begin to go outside during daylight hours, staying in shaded areas or going out when it is cloudy. Continue to wear dark, closely woven clothing.
Go outdoors on day 8 for 10 to 15 minutes; if you do not see any skin redness in the next 24 hours, gradually increase the time outdoors during the week.
Avoid direct sunlight or strong indoor lighting; stay in the shade.

Day 15 onwards Sensitivity to light is gradually returning to normal. Test carefully by exposing the back of the hand to the sun for 5 minutes. If there is no redness after 24 hours, you can gradually increase exposure to sunlight day by day. If there is redness, avoid direct sunlight for another 24 hours and repeat the test. Most people will be able to return to their normal routine by day 22.

Do not stay in the sunlight for more than 15 minutes the first time. Increase exposure by 15 minutes per day but if at any time you notice a prickly or burning sensation in the skin or see skin reddening after exposure to the sun, wait until this disappears before exposing skin to light for this length of time again.

For 30 days after injection with temoporfin, avoid eye tests that use bright lights.

Do not sunbathe for 3 months following injection with temoporfin and do not use UV tanning beds.

Avoid prolonged exposure to direct sunlight of the injection site arm for 6 months following treatment. If outdoor activity is planned the arm should be protected by wearing a long sleeved coloured shirt

Pregnancy and Lactation

Pregnancy

Temoporfin is contraindicated for use during pregnancy.

At the time of writing there are no data from the use of temoporfin in pregnant women. Animal studies are insufficient with respect to effects on foetal development and the potential risk for humans is not known.
Animal studies suggest a toxic effect in early pregnancy therefore it is recommended to avoid pregnancy for 3 months after treatment.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Breastfeeding is contraindicated for at least one month after injection.

It is not known if temoporfin is excreted in human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Extreme photosensitivity Pain on injection Local reaction at injection site Local infection Anaemia Dizziness Burning sensation Haemorrhage Constipation Dysphagia Vomiting Nausea Oral ulceration Blistering Erythema Hyperpigmentation Skin necrosis Trismus Face pain Facial oedema Fever Oedema Scar Sunburn Necrotising stomatitis Prickly sensation Pain

Presentation

Solution for injection containing temoporfin 3mg in 3ml.
Solution for injection containing temoporfin 6mg in 6ml.

Drugs List

Therapeutic Indications

Uses

Palliative treatment of patients with advanced head and neck squamous cell carcinoma not responsive to previous treatment and unsuitable for radiotherapy, surgery or systemic chemotherapy.

Dosage

Adults

Elderly

Children

Administration

Temoporfin is administered via an indwelling intravenous cannula in a large proximal limb vein, preferably in the antecubital fossa, as a single, slow intravenous injection over not less than 6 minutes. The patency of the indwelling cannula should be tested before injection and every precaution taken against extravasation.

An in-line filter must be used as a precautionary measure and is provided in the package with the injection. Do NOT flush with sodium chloride solution or any other aqueous solution.

Transient injection site pain can be reduced by slowing the injection rate.

Contraindications

Porphyria or other diseases exacerbated by light
Known allergies to porphyrins
Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
A planned surgical procedure within the next 30 days
Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days
Pregnancy
Breastfeeding
Children under 18 years

Precautions and Warnings

Temoporfin photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy.

Take special care to prevent extravasation at the injection site. If extravasation occurs, protect the area from light for at least 3 months. There is no known benefit from injecting the extravasation site with another substance.

Some pulse oximeters may product light of a wavelength close to that used for the photo activation of temoporfin. Oximeters must be repositioned at least every 10 to 15 minutes to avoid the risk of local skin burns.

Unplanned or emergency surgical procedure within 30 days of administration of temoporfin must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient. All precautions must be taken to avoid direct illumination of the patient with surgical lamps during these procedures.

Women of child-bearing age must use effective contraception for 3 months after treatment with temoporfin.

All patients who receive temoporfin will become temporarily photosensitive. During the first 15 days after injection precautions must be taken to avoid exposure of the skin or eyes to direct sunlight or bright indoor light.

Skin photosensitivity reactions are caused by visible light, therefore ultraviolet sunscreens do not
provide protection. It is important that patients are re-introduced to normal light gradually.

Clinicians must counsel patients to observe the necessary precautions (see below) and provide them with a copy of the patient information leaflet.

Prevention of photosensitivity reactions/burns

Day 1 (0 - 24 hours after injection) Stay indoors in a darkened room. Keep the curtain drawn and use light bulbs of 60W or less. Avoid exposure to direct sunlight.

Days 2 - 7 Gradually return to normal indoor lighting. Avoid direct sunlight coming through the window or direct light from household appliances, such as reading lamps. You may watch television and go outdoors after dusk.

If it is essential to go outdoors during daylight hours, cover up all skin including face and hands and wear dark glasses. Appropriate clothing is dark and closely woven (thin clothing will not provide adequate protection against strong light). Wear the following:
Wide-brimmed hat for head, neck, nose and ears,
Scarf for head and neck
Sunglasses with side-panels for eyes and surrounding skin,
Long-sleeved top for upper body/arms,
Long trousers for lower body/legs,
Gloves for hands, wrist and fingers,
Socks and closed shoes for feet and ankles.

If you are exposed to light by mistake, you may get a prickly or burning feeling on the skin. You must get out of the light immediately.
Your eyes may be very sensitive to bright lights during this week. If you get eye pain or headache when lights are switched on, wear dark glasses.

Days 8 - 14 Begin to go outside during daylight hours, staying in shaded areas or going out when it is cloudy. Continue to wear dark, closely woven clothing.
Go outdoors on day 8 for 10 to 15 minutes; if you do not see any skin redness in the next 24 hours, gradually increase the time outdoors during the week.
Avoid direct sunlight or strong indoor lighting; stay in the shade.

Day 15 onwards Sensitivity to light is gradually returning to normal. Test carefully by exposing the back of the hand to the sun for 5 minutes. If there is no redness after 24 hours, you can gradually increase exposure to sunlight day by day. If there is redness, avoid direct sunlight for another 24 hours and repeat the test. Most people will be able to return to their normal routine by day 22.

Do not stay in the sunlight for more than 15 minutes the first time. Increase exposure by 15 minutes per day but if at any time you notice a prickly or burning sensation in the skin or see skin reddening after exposure to the sun, wait until this disappears before exposing skin to light for this length of time again.

For 30 days after injection with temoporfin, avoid eye tests that use bright lights.

Do not sunbathe for 3 months following injection with temoporfin and do not use UV tanning beds.

Avoid prolonged exposure to direct sunlight of the injection site arm for 6 months following treatment. If outdoor activity is planned the arm should be protected by wearing a long sleeved coloured shirt

Pregnancy and Lactation

Pregnancy

Temoporfin is contraindicated for use during pregnancy.

At the time of writing there are no data from the use of temoporfin in pregnant women. Animal studies are insufficient with respect to effects on foetal development and the potential risk for humans is not known.
Animal studies suggest a toxic effect in early pregnancy therefore it is recommended to avoid pregnancy for 3 months after treatment.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Breastfeeding is contraindicated for at least one month after injection.

It is not known if temoporfin is excreted in human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

Patients should be advised not to drive for the first 15 days after injection, and to use machines only if practical to do so under subdued lighting conditions according to the recommended lighting precautions.

Driving and use of machines may resume under normal lighting or daylight conditions once photosensitivity has been shown to have subsided.

Counselling

All patients receiving temoporfin will become temporarily photosensitive and must be instructed to observe the precautions in the patient information leaflet. (see Warnings)

Advise women of child-bearing age to use effective contraception for 3 months after treatment with temoporfin.

For 30 days after injection with temoporfin, avoid eye tests that use bright lights.

Do not sunbathe for 3 months following injection with temoporfin and do not use UV tanning beds.

Advise patient to avoid prolonged exposure to direct sunlight to the injection site arm for 6 months following treatment. If outdoor activity is planned the arm should be protected by wearing a long sleeved coloured shirt.

Patients should also be advised that driving or operating machines in subdued light may be hazardous and that it may be necessary not to resume these activities until photosensitivity has subsided.

Side Effects

Extreme photosensitivity Pain on injection Local reaction at injection site Local infection Anaemia Dizziness Burning sensation Haemorrhage Constipation Dysphagia Vomiting Nausea Oral ulceration Blistering Erythema Hyperpigmentation Skin necrosis Trismus Face pain Facial oedema Fever Oedema Scar Sunburn Necrotising stomatitis Prickly sensation Pain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Do not store above 25 degrees C.

Protect from light by storing in the original container and keeping the container in the outer package.

Further Information

Last Full Review Date: January 2013

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Foscan. Biolitec Pharma. Revised April 2011.