What is Kisunla?

Kisunla (donanemab) is a prescription medicine used for the mild dementia stage of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) due to Alzheimer’s disease. Kisunla is a plaque-targeting therapy that helps to slow down the decline in memory, thinking, and daily functioning. This slows the progression of Alzheimer’s disease so people can continue their daily activities and hobbies and live independently for a longer time. Kisunla is given as a once-monthly IV infusion.

Alzheimer’s disease symptoms are thought to be related to clumps of amyloid protein (amyloid plaques) that can occur in the brain. Kisunla is an amyloid plaque-targeting therapy that works by helping the body remove amyloid plaques in the brain, which slows the progression of Alzheimer’s disease.

Kisunla FDA approval was received on July 2, 2024, as a treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with mild dementia stage of AD, with confirmed amyloid pathology. Kisunla is an Eli Lilly and Company product.

How well does it work?

Kisunla (donanemab) significantly slowed Alzheimer’s disease progression by more than 20% at 76 weeks in the TRAILBLAZER-ALZ 2 clinical trial. This was measured using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score in patients with low/medium tau and in the combined low/medium and high tau populations.

Treatment with Kisunla benefited all groups of trial participants, but patients in earlier stages of the disease showed the most significant improvements.

Kisunla side effects

Common Kisunla side effects

Common Kisunla side effects include headache and swelling in areas of the brain with or without small spots of bleeding in or on the brain’s surface. These occurred in at least 10% of patients and at a higher incidence compared to placebo.

Serious Kisunla side effects

• Serious allergic reactions include swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.
• Infusion-related reactions. If you have an infusion-related reaction, your infusion may be slowed down or stopped. Tell your healthcare provider right away if you have symptoms of sweating, irritation of the skin, headache, nausea, chest pain, vomiting, or problems breathing during an infusion chills. If you have had an infusion-related reaction while receiving Kisunla, your healthcare provider may give you an antihistamine, acetaminophen, or a steroid before your infusions to decrease your risk of having an infusion reaction.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Kisunla can cause serious side effects, including:

Amyloid Related Imaging Abnormalities or ARIA.

ARIA is a common side effect that does not usually cause any symptoms, but sometimes serious symptoms can occur. ARIA can be fatal. It is most commonly seen in an MRI as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur.

Most people who develop ARIA do not have symptoms; however, some people may have symptoms such as headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures.

If you have any of the symptoms of ARIA listed above, you should call your healthcare provider or go to the nearest hospital emergency room right away.

You are more at risk of ARIA if you have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers). Your healthcare provider may test to see if you have this risk factor.

If you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla, you may be at a higher risk of developing bleeding in the brain.

Magnetic resonance imaging (MRI) scans are done before and during your treatment to check you for ARIA.

You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms.

There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries.

Consider the risk of ARIA and the benefit of Alzheimer’s disease when deciding to treat with Kisunla.

Who should not take Kisunla?

You should not receive this medicine if you have had serious allergic reactions to donanemab-azbt or any of the ingredients in this infusion. See the end of this document for a complete list of ingredients.

Before taking this medicine

Pregnancy

Tell your healthcare provider if you plan to become pregnant, become pregnant, or are pregnant, as it is not known if this medicine will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed, as it is not known if the active ingredient in Kisunla passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

How will I receive this medicine?

Kisunla is given as an infusion into a vein (IV infusion) in your arm, which will last about 30 minutes.
Kisunla is given every 4 weeks. If you miss an infusion, you should receive your next dose as soon as possible.

Kisunla Dosing information

Usual Adult Kisunla dose: 700 mg every four weeks for three doses, then 1400 mg every four weeks.

Comments

• Kisunla is given every four weeks as an intravenous infusion over approximately 30 minutes, it must be diluted prior to administration.
• Consider stopping dosing with Kisunla based on the reduction of amyloid plaques to minimal levels on amyloid PET imaging.
• If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.

Kisunla is available as: 350 mg/20 mL (17.5 mg/mL) in a single-dose vial.

Storage

Unopened Vial

Store refrigerated at 2°C to 8°C (36°F to 46°F).

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

Do not freeze or shake.

If refrigeration is not available, it may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 3 days.

Diluted Solution

After dilution, immediate use is recommended.

Diluted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.

Do not freeze the diluted solution.

Storage times include the duration of infusion.

Ingredients

Active ingredient: donanemab-azbt

Inactive ingredients: anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, and Water for Injection, USP.

Manufacturer

Eli Lilly and Company, Indianapolis, IN 46285, USA

Kisunla Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kisunla.Kisunla (donanemab-azbt) – Eli Lilly and Company

What is Leqembi?

Leqembi (lecanemab) is used for Alzheimer’s disease to help slow the decline in memory, thinking, and behavior in patients who have mild cognitive impairment (MCI) or mild dementia. Leqembi infusion works by reducing amyloid beta plaques in the brain, which helps slow down the worsening of dementia symptoms.

In a clinical trial (Clarity AD), Leqembi patients experienced a 27% slower rate of cognitive decline over 18 months compared to those who received a placebo.  Leqembi helps control Alzheimer’s disease but does not cure it. 

Leqembi infusion is given every 2 weeks and takes approximately 1 hour, after 18 months of treatment, this may be extended to every 4 weeks.

How does Leqembi work?

Alzheimer’s disease is a type of dementia that affects memory, thinking, and behavior, which can eventually grow severe enough to interfere with daily tasks. One of the causes of Alzheimer’s disease is thought to be abnormal buildup in the brain of a protein (amyloid) into clumps or plaques which makes it harder for brain cells to communicate with each other and results in the symptoms of Alzheimer’s disease. 

Leqembi infusion works by selectively targeting amyloid beta proteins before they form plaques and also helps to remove plaques that have already formed. By helping to reduce amyloid beta plaque buildup, Leqembi infusion helps to slow the decline of Alzheimer’s Disease.

Leqembi mechanism of action is as an amyloid beta-directed antibody against aggregated soluble and insoluble forms of amyloid beta.

Who can use Leqembi?

Leqembi approval is to treat Alzheimer’s disease in patients who have:

• mild cognitive impairment or mild dementia due to Alzheimer’s disease, and
• presence of amyloid beta pathology.

Leqembi FDA approval was granted on January 6, 2023, to Eisai Inc.

Leqembi side effects

Common Leqembi side effects 

The most common side effects of Leqembi infusion are:

• infusion-related reactions, which can be serious
• headache
• swelling in areas of the brain, with or without small bleeding spots in or on the brain’s surface (ARIA).

Infusion-related reactions. Infusion-related reactions occurred in 26% of Leqembi patients compared to 7% of placebo patients. Symptoms of infusion reactions are:

• fever
• flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain),
• nausea and vomiting,
• low blood pressure (hypotension),
• high blood pressure (hypertension),
• and oxygen desaturation. 

Managing infusion-related reactions. If you have an infusion-related reaction the infusion rate may be reduced, or the infusion may be stopped, and appropriate therapy may be started as clinically indicated. Before future infusions, preventative (prophylactic) treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids may be considered.

The most common side effects occurred in 10% or more of patients and were higher than the side effect incidence compared to placebo.

Serious Leqembi side effects and warnings

Leqembi carries a Boxed Warning for Amyloid-related imaging abnormalities.

Amyloid Related Imaging Abnormalities or “ARIA”. This medicine can cause a condition called ARIA which does not usually cause any symptoms but serious symptoms can occur. ARIA is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. Most people with this type of swelling in the brain do not get symptoms, however, some people may have symptoms, such as headache, confusion, dizziness, vision changes, nausea, difficulty walking, or seizures.

Some people have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

Some medicines can increase the risk for larger areas of bleeding in the brain in patients taking this medicine. Talk to your healthcare provider to see if you are on any medicines that increase this risk.

Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with this medicine to check you for ARIA. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

Serious allergic reactions. Swelling of the face, lips, mouth, or tongue, hives, or difficulty breathing has happened during a Leqembi infusion. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.

Infusion-related reactions. Infusion-related reactions are a common side effect that can be serious. 

These are not all the possible side effects of Leqembi. For more information, ask your healthcare provider or pharmacist, or see the below for more detailed information on side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Leqembi cost

Leqembi’s cost will depend on your insurance coverage and Leqembi Copay eligibility. For links to enrollment forms for the Copay Cards and Patient Assistance Program (PAP) .

Before receiving this medicine

Do not receive this medicine if you are allergic to the active ingredient lecanemab or any of the inactive ingredients in this medicine. See below for a list of inactive ingredients. 

Tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed. 

Pregnancy

It is not known if this medicine will harm your unborn baby. Tell your healthcare provider if you become pregnant during Leqembi treatment.

Breastfeeding

It is not known if Leqembi passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

How will I receive this medicine?

Leqembi is administered by a healthcare provider through an intravenous (IV) infusion, which involves inserting a needle into a vein in your arm.

• Leqembi is given every 2 weeks for the first 18 months, and then this may be extended to every 4 weeks.
• Each infusion will last about 1 hour.

You may receive medications before your infusion, such as antihistamines, anti-inflammatories, or steroids, to reduce your risk of having an infusion-related reaction. Tell your healthcare provider right away if you get symptoms of an infusion-related reaction. See infusion-related reaction symptoms in the side effects section.

Leqembi dose information

Usual Leqembi Dose for Alzheimer’s Disease (Adult):

• The recommended Leqembi dosage is 10 mg/kg.
• The injection is diluted and then administered as an intravenous infusion over approximately one hour, once every two weeks for the first 18 months, and then this may be extended to every 4 weeks.

Leqembi is available as:

•  500 mg/5 mL (100 mg/mL) in a single-dose vial.
•  200 mg/2 mL (100 mg/mL) in a single-dose vial.

Leqembi Package Insert 

Review the Leqembi Package Insert (PI) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the Prescribing Information (PI) or the FDA label.

What other drugs will affect this medicine?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.  

Ingredients

Active ingredient: lecanemab-irmb.
Inactive ingredients: arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injection.

Storage

Unopened Vial Storage:

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Store in the original carton to protect from light.  
• Do not freeze or shake.

After vial dilution

• Immediate use is recommended 
• If not administered immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours, or at room temperature up to 30°C (86°F) for up to 4 hours.
• Do not freeze.

Leqembi Manufacturer

Leqembi manufacturer Eisai Inc. Nutley, NJ 07110.

Leqembi Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Leqembi.Leqembi (lecanemab-irmb) – Eisai, Incorporated

What is memantine?

Memantine is used to treat moderate to severe dementia in people with Alzheimer’s disease (AD). It is an oral tablet or capsule that is taken once or twice a day.

Memantine works to help relieve symptoms of AD by blocking NMDA receptors that, when persistently activated by glutamate, cause AD symptoms. While this mechanism helps to manage symptoms, memantine has not been shown to prevent or slow the underlying nerve degeneration associated with AD. Memantine belongs to the drug class called N-methyl-D-aspartate (NMDA) receptor antagonists. 

Memantine was FDA-approved on October 16, 2003, under the brand name Namenda. Generic memantine became available in 2010.

Side effects

The most common side effects of memantine include:

• dizziness
• headache
• confusion
• constipation.

Serious side effects and warnings

Memantine can cause serious allergic reactions, including anaphylaxis. Get emergency medical help if you have signs of an allergic reaction to memantine with symptoms such as hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Conditions that increase the pH of the urine (such as kidney disease, prolonged vomiting, and some medications) may decrease how much memantine is excreted, which may increase blood levels of memantine. Tell your healthcare provider about all your medical conditions.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears
• seizure (convulsions)
• unusual changes in mood or behavior.

These are not all the possible side effects of memantine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA

Before taking

Before taking memantine, tell your doctor if you are allergic to memantine, Namenda, or any inactive ingredients in the tablets or capsules.

Tell your healthcare provider about all your medical conditions, including if you:

• have a seizure disorder
• have cataracts
• have liver or kidney disease
• have a bladder or kidney infection
• have problems passing urine
• are pregnant or intending to become pregnant
• are breastfeeding.

It is not known if memantine is safe and effective in children.

Pregnancy

It is not known if memantine will harm an unborn baby.

Breastfeeding

It is not known if memantine passes into your breast milk. Talk to your doctor about the best way to feed your baby during treatment.

How should I take memantine?

Your doctor will tell you how much memantine to take and when to take it.

Memantine tablets or extended-release capsules may be taken with food or without food.

• Do not use any tablets or capsules of memantine that are damaged or show signs of tampering.
• Memantine hydrochloride extended-release capsules should be swallowed whole or may be opened and the contents sprinkled on applesauce and then swallowed. The entire contents of each memantine hydrochloride extended-release capsule should be consumed; the dose should not be divided.

Dosing information

Memantine immediate-release tablets

Initial dose: 5 mg once daily.

Titration: Increase by 5 mg increments once a week.

Maximum dosage: 10 mg twice daily.

• In people with severe kidney disease, the maximum dose is 5mg twice daily.

Memantine extended-release capsules

Initial dose: 7 mg once daily.

Titration: Increase by 7 mg increments once a week.

Maintenance dose: 28 mg once daily.

Maximum dosage: 28 mg once daily.

• In people with severe kidney disease, the maximum dose is 14 mg once daily.

Switching from memantine tablets to memantine extended-release capsules

People on a regimen of 10 mg twice daily of memantine tablets can be switched to memantine extended-release 28 mg once daily capsules the day following the last dose of 10 mg memantine hydrochloride.

People with severe renal impairment taking 5 mg twice daily of memantine should be switched to memantine extended-release 14 mg once daily capsules the day following the last dose of 5 mg memantine tablets.

What happens if I forget a dose?

If you forget to take one dose of memantine, do not double up on the next dose. You should take only the next dose as scheduled.

If you have forgotten to take memantine for several days, you should not take the next dose until you talk to your doctor.

What happens if I overdose?

If you take too much memantine, call your doctor or poison control center right away, or go to the nearest hospital emergency room.

What should I avoid?

Memantine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect memantine?

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking memantine with certain other medicines may affect each other or cause serious side effects. Especially tell your doctor if you take:

• other NMDA antagonists such as amantadine, ketamine, and dextromethorphan
• medicines that make your urine alkaline, such as carbonic anhydrase inhibitors and sodium bicarbonate.

Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Storage

Store memantine tablets and capsules at room temperature between 59°F to 77°F (15°C to 30°C).

Ingredients

Namenda ingredients

Active ingredient: memantine hydrochloride.

Inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate.

Inactive ingredients of tablet film coating: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).

Available as Namenda 5 mg and 10 mg tablets and Namenda XR (extended-release capsule) 7 mg, 14 mg, 21 mg, 28 mg.

Generic memantine ingredients

Active ingredient: memantine hydrochloride

Inactive ingredients: These vary depending on the manufacturer.

Available as memantine 5 mg and 10 mg tablets and memantine XR (extended-release capsule) 7 mg, 14 mg, 21 mg, 28 mg.

Who makes memantine?

Namenda (memantine) was originally manufactured by Forest Laboratories, which was acquired by Allergan in 2014, which was subsequently acquired by AbbVie in 2020. AbbVie is headquartered in North Chicago, Illinois, USA.

The original brand name Namenda, is now also available as a generic medication (memantine) from multiple manufacturers, including Amneal Pharmaceuticals LLC, Aurobindo Pharma Limited, and Sun Pharmaceutical Industries, Inc., as the patent protection has expired.

What is Namenda?

Namenda (memantine) reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer’s disease.

Namenda is used to treat moderate to severe dementia of the Alzheimer’s type.

Namenda’s mechanism of action is to help balance a brain chemical called glutamate. In Alzheimer’s, there can be too much glutamate activity, which can harm brain cells. By controlling glutamate, Namenda may help protect brain cells from damage and improve memory and thinking skills in some people with Alzheimer’s. Namenda is not a cure for Alzheimer’s.

Because Namenda works differently from other Alzheimer’s medications it may be prescribed along with other Alzheimer’s drugs for better results. Namenda belongs to the drug class called NMDA (N-methyl-D-aspartate) inhibitors.

Namenda gained FDA approval on October 16, 2003. A Namenda generic is available under the name memantine.

Namenda side effects

The most common Namenda side effects are:

• dizziness
• headache
• confusion
• constipation.

Serious side effects and warnings

Your body gets rid of Namenda through your urine. Some health conditions, such as a urinary tract infection, kidney disease, medications, or diet can make your urine less acidic (raise its pH). If this happens, your body might not remove Namenda as well as it should. This could cause more Namenda to stay in your blood than usual.

Namenda can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything requiring you to be alert.

Namenda may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Namenda: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking this medicine

Do not take Namenda if you are allergic to memantine, Namenda, or any of the inactive ingredients in the tablets (see the ingredient list below).

Before taking Namenda, tell your doctor about all your medical conditions including if you have:

• have or have had seizures or epilepsy
• have liver disease
• have kidney disease
• have problems passing urine
• have a bladder or kidney infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Namenda will harm an unborn baby.

Breastfeeding

It is not known if Namenda passes into breast milk or if it could harm a nursing baby. Talk to your doctor about the best way to feed your baby if you take Namenda.

How do I take Namenda?

Take Namenda exactly as it was prescribed for you. Follow all directions on your prescription label and do not take this medicine in larger or smaller amounts or for longer than recommended.

• Namenda is usually taken once or twice daily (see Namenda dosage below).
• Namenda can be taken with or without food.
• Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

To make swallowing easier, you may open the extended-release capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Use Namenda regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

• Your doctor will need to check your progress while you are using Namenda.

Namenda dosing information

Usual Adult Dose of Namenda for Alzheimer’s Disease:

IMMEDIATE-RELEASE:
Initial dose: Namenda 5 mg orally once a day, then titrated upwards by 5 mg per week
Maintenance dose: Namenda 5 mg once a day up to Namenda 10 mg twice a day
Maximum dose: 20 mg per day

EXTENDED-RELEASE:
Initial dose: Namenda XR 7 mg orally once a day, then titrated upwards by 7 mg per week
Maintenance dose: Namenda XR 7 mg once a day up to Namenda XR 28 mg once a day
Maximum dose: 28 mg orally once a day

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

If you miss doses or forget to take your medicine for several days, call your doctor before starting the medicine again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Namenda can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything requiring you to be alert.

What other drugs will affect Namenda?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• amantadine
• ketamine
• zonisamide
• cough medicine that contains dextromethorphan (Delsym, Robitussin Maximum Strength, Vicks 44, and others)
• medicines to make the urine alkaline – urine sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra) (can reduce the clearance of Namenda by about 80%)
• medicine to treat glaucoma or increased pressure inside the eyes – acetazolamide, methazolamide.

This list is not complete. Other drugs may interact with memantine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Namenda ingredients

Active ingredient: memantine hydrochloride 5 mg or 10 mg

Inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate

Inactive ingredients of tablet film coating: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).

Available as Namenda 5 mg tablets and Namenda 10 mg tablets.

Storage

Store Namenda at room temperature between 59°F to 77°F (15°C to 30°C) away from moisture and heat.

Who makes Namenda?

Merz Pharmaceuticals GmbH makes Namenda which is distributed by Allergan USA, Inc.

What is Qalsody?

Qalsody (tofersen) is a prescription medicine used to treat amyotrophic lateral sclerosis (ALS) in adults who have a specific genetic mutation in the superoxide dismutase 1 (SOD1) gene. Qalsody is the first FDA-approved treatment that targets a genetic cause of ALS to slow progression of ALS. Qalsody works by reducing the amount of a toxic protein (SOD1 protein) that causes damage to motor neurons and the symptoms of ALS .

ALS  patients who have a mutation in the SOD1 gene (SOD1-ALS) make a toxic misfolded form of SOD1 protein that damages the motor neurons which causes muscle weakness, loss of function, and in time even death. Qalsody is an antisense oligonucleotide (ASO) that lowers the amount the toxic SOD1 protein made by binding to SOD1 mRNA, which may help slow the progression of ALS.

Warnings

Qalsody can cause serious side effects, contact your doctor immediately if you have:

Inflammation of the spinal cord (myelitis) and/ or irritation of the nerve roots (radiculitis) can occur in patients treated with Qalsody. Discuss with your healthcare provider to learn about the symptoms associated with myelitis or radiculitis. Treatment with Qalsody may need to be interrupted or discontinued.

Swelling of the optic nerve (papilledema) and increased pressure inside the skull (elevated intracranial pressure ) can occur in patients treated with Qalsody.  Discuss with your healthcare provider what the symptoms associated with papilledema or elevated intracranial pressure are.

Inflammation of the brain linings (aseptic meningitis) can occur in patients treated with Qalsody in patients treated with Qalsody. Discuss with your healthcare provider to learn more about symptoms associated with aseptic meningitis.

What should I tell my doctor before taking Qalsody?

Before taking this medicine it is important to tell your healthcare provider if you are pregnant or planning to become pregnant or are breastfeeding or planning to breastfeed.

How is Qalsody administered?

 Qalsody is administered intrathecally using a lumbar puncture, this means that it is given as an injection into the spinal canal.

Dosing information

Loading dose: 100 mg intrathecally every 14 days for 3 doses

Maintenance dose: 100 mg intrathecally every 28 days

Comments:

• Consider utilizing patient sedation and/or imaging techniques to facilitate administration of this drug.
•  Before administering this medicine remove 10 mL from cerebrospinal fluid and then administer Qalsody as an intrathecal bolus injection over 1 to 3 minutes using a lumbar puncture needle.
• If the second loading dose is missed, administer it as soon as possible, and administer the third loading dose 14 days later.
• If the third loading dose or a maintenance dose is missed, administer it as soon as possible, and administer the next dose 28 days later.

Use: For the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Dosage form: Injection 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial that is free of preservatives.

What are the side effects of Qalsody?

Common Qalsody side effects may include:

• pain including back pain and pain in arms or legs
• feeling tired
• muscle and joint pain
• increased white blood cell count in the cerebrospinal fluid (CSF).

Less Common but serious side effects include:

• myelitis and radiculitis (see warnings above)
• papilledema and elevated intracranial pressure (see warnings above)
• aseptic meningitis (see warnings above)